President's Emergency Plan for AIDS Relief (PEPFAR) Database
PEPFAR Applications
to Date = 258
Number of Products =
324
| Application No. | Approval Status | Established Name | Strength | Company | Application Type | Manufacturer | Supplier | Date of FDA Approval or Tentative Approval | Packaging Material and Pack | Current Approval Status | Labeling | Active Ingredient | Dosage Form | Drug Product Manufacturing Site | Co-Packaged | Formulation | Approved for Pediatrics | Pediatric Indication Notes | Storage Conditions | Shelf-life (Months) | Scoring | Application Status History | Country of Origin | Company Contact Info | FDA Original Action Sequence for PEPFAR | Currently Manufactured |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 021837 | Tentatively Approved | Lamivudine, Stavudine, and Nevirapine Tablets | 150 mg/40 mg/200 mg | Strides Pharma Global PTE Limited. | NDA | Strides Pharma Science Limited | Strides Acrolab Limited | 03/20/2008 | HDPE bottles of 60. | Tentatively Approved | View Label | Lamivudine, Stavudine, and Nevirapine | Tablets | Strides Pharma Science Limited No 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bengaluru, Karnataka, India. 562106 | No | 3-Fixed Dose Combination | Yes | For Pediatric patients at least 12 years of age and weighing at least 50 kg. | Store below 25°C. | 24 | Not Scored | Tentatively Approved 3/20/2008 | India | http://www.strides.com/contact.aspx | 64 | No |
| 021838 | Tentatively Approved | Stavudine and Lamivudine Tablets | 30 mg/150 mg | Strides Pharma Global PTE Limited. | NDA | Strides Pharma Science Limited | Strides Pharma Global PTE Limited. | 03/13/2007 | HDPE bottle of 60 tablets with non child-resistant snap on cap and tamper evident strip. | Tentatively Approved | View Label | Stavudine and Lamivudine | Tablets | Strides Pharma Science Limited No 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bengaluru, Karnataka, India. 562106 | No | 2-Fixed Dose Combination | Yes | For Pediatric patients at least 12 years of age and weighing at least 60 kg. | Store below 25°C. Protect from light. | 24 | Not Scored | Tentatively Approved 3/13/2007 | India | http://www.strides.com/contact.aspx | 38 | No |
| 021841 | Withdrawn | Lamivudine / Zidovudine Tablets Co-packaged with Nevirapine Tablets | 150 mg/300 mg + 200 mg | Pharmacare Limited | NDA | Withdrawn | Lamivudine / Zidovudine Co-packaged with Nevirapine | Tablets | No | 4-Fixed Dose Combination | Yes | Not Scored | Withdrawn 1/19/2017 Tentatively Approved 1/24/2005 | http://www.pharmacarelimited.com/contactus | 2 | No | ||||||||||
| 021854 | Tentatively Approved | Stavudine / Lamivudine Tablets Co-packaged with Nevirapine Tablets | 40 mg/150 mg + 200 mg | Strides Pharma Global PTE Limited. | NDA | Strides Pharma Science Limited | Strides Pharma Global PTE Limited. | 03/13/2007 | Co-packaged in a carton contains two HDPE bottles of 60 tablets of Stavudine/Lamivudine and Nevirapine respectively, with non child-resistant snap on cap and tamper evident strip (60 unit doses per carton). | Tentatively Approved | View Label | Stavudine / Lamivudine Co-packaged with Nevirapine | Tablets | Strides Pharma Science Limited No 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bengaluru, Karnataka, India. 562106 | Yes | 4-Fixed Dose Combination | Yes | For pediatric patients older than 12 years of age and weighing at least 60 kg. | Store below 30°C. Protect from light. | Not Scored | Tentatively Approved 3/13/2007 | India | http://www.strides.com/contact.aspx | 39 | No | |
| 021939 | Tentatively Approved | Lamivudine, Zidovudine, and Nevirapine Tablets | 150 mg/300 mg/200 mg | Aurobindo Pharma Limited | NDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 06/30/2006 | HDPE bottle of 60. Carton of 60 unit dose tablets in blister packs (6x10). | Tentatively Approved | View Label | Lamivudine, Zidovudine, and Nevirapine | Tablets | Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090 Aurobindo Pharma Limited Unit-VII, Sy.No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No.S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India. 509302. | No | 3-Fixed Dose Combination | Yes | For Pediatric patients at least 12 years of age and weighing at least 50 kg. | Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). | 36 | Not Scored | Tentatively Approved 6/30/2006 | India | https://www.aurobindousa.com/contact-us/ | 24 | No |
| 021943 | Tentatively Approved | Lamivudine / Zidovudine Tablets Co-packaged with Efavirenz Tablets | 150 mg/300 mg + 600 mg | Aurobindo Pharma Limited | NDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 03/06/2006 | Carton of 30 co-packages, consisting of 6 blister packs. Each blister card contains five copackages and each copackage contains 2 Lamivudine / Zidovudine tablets with 1 Efavirenz tablets 6x (5x3's). | Tentatively Approved | View Label | Lamivudine / Zidovudine Co-packaged with Efavirenz | Tablets | Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090. Aurobindo Pharma Limited Unit-VII, Sy.No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No.S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India. 509302. | Yes | 4-Fixed Dose Combination | Yes | For Pediatric patients at least 12 years of age and weighing at least 40 kg. | Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). | 36 | Not Scored | Tentatively Approved 3/06/2006 | India | http://www.aurobindousa.com/contact-us/ | 16 | No |
| 021944 | Tentatively Approved | Lamivudine / Zidovudine Tablets Co-packaged with Abacavir Tablets | 150 mg/300mg + 300 mg | Aurobindo Pharma Limited | NDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 07/26/2006 | Carton containing 6 blister packs, each blister card contains five co-packages and each co-package contains two lamivudine/ zidovudine tablets and two abacavir tablets 6X(5X4) | Tentatively Approved | View Label | Lamivudine / Zidovudine Co-packaged with Abacavir | Tablets | Aurobindo Pharma Limited Unit-III, Sy. No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090. | Yes | 4-Fixed Dose Combination | Yes | For Pediatric patients at least 12 years of age and weighing at least 40 kg. | Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). | 24 | Scored | Tentatively Approved 7/26/2006 | India | https://www.aurobindousa.com/contact-us/ | 26 | No |
| 021969 | Withdrawn | Stavudine, Lamivudine, and Nevirapine Tablets | 150 mg/40 mg/200 mg, 150 mg/30 mg/200 mg | Cipla Limited | NDA | Withdrawn | Stavudine, Lamivudine, and Nevirapine | Tablets | No | 3-Fixed Dose Combination | Yes | Not Scored | Withdrawn 3/15/2016 Tentatively Approved 11/17/2006 | https://www.cipla.com/en/contact-us.html | 33 | No | ||||||||||
| 021971 | Tentatively Approved | Lamivudine, Zidovudine, and Nevirapine Tablets | 150 mg/300 mg/200 mg | Cipla Limited | NDA | Cipla Limited | Cipla Limited | 01/31/2007 | HDPE bottles of 30, 60 and 500. | Tentatively Approved | View Label | Lamivudine, Zidovudine, and Nevirapine | Tablets | Cipla Limited -Goa Unit 3, Unit 4, Unit 7, Verna Industrial Area, Verna Salcette, Verna, Goa, India 403722 Cipla Limited -Indore Unit IV, Plot No. 9, 10 & 15, Indore Special Economic Zone, Phase II, Pithampur, District Dhar, Madhya Pradesh, India 454775 | No | 3-Fixed Dose Combination | Yes | For pediatric patients at least 12 years of age and weighing at least 50Kg | Store at 15°C - 25°C (59°F - 77°F) | 24 | Not Scored | Tentatively Approved 1/31/2007 | India | https://www.cipla.com/en/contact-us.html | 36 | Yes |
| 021972 | Withdrawn | Stavudine, Lamivudine, and Nevirapine Tablets for Oral Suspension | 30 mg/6 mg/50 mg, 60 mg/12 mg/100 mg | Cipla Limited | NDA | Withdrawn | Stavudine, Lamivudine, and Nevirapine | Tablets for Oral suspension | No | 3-Fixed Dose Combination | Yes | Not Scored | Withdrawn 3/7/2017 Tentatively Approved 8/13/2007 | https://www.cipla.com/en/contact-us.html | 51 | No | ||||||||||
| 021974 | Withdrawn | Stavudine and Lamivudine Tablets | 150 mg/30 mg, 150mg/40 mg | Cipla Limited | NDA | Withdrawn | Stavudine and Lamivudine | Tablets | No | 2-Fixed Dose Combination | Yes | Not Scored | Withdrawn 3/11/2016 Tentatively Approved 1/19/2007 | https://www.cipla.com/en/contact-us.html | 35 | No | ||||||||||
| 021988 | Tentatively Approved | Lamivudine / Zidovudine Tablets Co-packaged with Nevirapine Tablets | 150 mg/300 mg + 200 mg | Strides Pharma Global PTE Limited. | NDA | Strides Pharma Science Limited | Strides Pharma Global PTE Limited. | 03/02/2007 | Co-packaged in a carton contains two HDPE bottles of 60 tablets of Lamivudine/Zidovudine and Nevirapine respectively, with non child-resistant snap on cap and tamper evident strip (60 unit doses per carton). | Tentatively Approved | View Label | Lamivudine / Zidovudine Co-packaged with Nevirapine | Tablets | Strides Pharma Science Limited No 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bengaluru, Karnataka, India. 562106 | Yes | 4-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 30 kg. | Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). | 24 | Scored | Tentatively Approved 3/02/2007 | India | http://www.strides.com/contact.aspx | 37 | Yes |
| 022018 | Withdrawn | Lamivudine and Zidovudine Tablets | 150 mg/300 mg | Pharmacare Limited | NDA | Withdrawn | View Label | Lamivudine and Zidovudine | Tablets | No | 2-Fixed Dose Combination | Yes | 24 | Not Scored | Withdrawn 11/26/2019 Approved 3/17/2018; TA'd 10/23/2006 | http://www.pharmacarelimited.com/contactus | 28 | No | ||||||||
| 022061 | Tentatively Approved | Lamivudine, Nevirapine, and Zidovudine Tablets | 150 mg/200 mg/300 mg | Mylan Laboratories Limited | NDA | Mylan Laboratories LimitedGranules India Limited | Mylan Laboratories Limited | 10/21/2008 | HDPE bottle of 60.Blister packs of 10 unit doses in cartons of 60 (6X10). | Tentatively Approved | View Label | Lamivudine, Nevirapine, and Zidovudine | Tablets | Mylan Laboratories Limited (FDF-1) Plot No. F-4 and F-12 Malegaon M.I.D.C., Sinnar Nashik District, Maharashtra, India. 422113 Mylan Laboratories Limited (FDF-2) Plot No. H-12 & H-13 MIDC, Waluj. Aurangabad, Maharashtra, India. 431136 Mylan Laboratories Limited (FDF-3) Plot No. 11, 12 and 13, Indore Special Economic Zone Pharma Zone, Phase-II, Sector-III, Pithampur Dhar district, Madhya Pradesh, India. 454775. Granules India Limited Plot No - 160/A, 161/E, 162, 163/A, 174/A Ga | No | 3-Fixed Dose Combination | Yes | For Pediatric patients at least 12 years of age. | Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F). | 36 | Not Scored | Tentatively Approved 10/21/2008 | India | https://www.mylan.com/en/contact-mylan | 77 | Yes |
| 022085 | Tentatively Approved | Lamivudine and Stavudine Tablets | 150 mg/30 mg, 150 mg/40 mg | Mylan Laboratories Limited | NDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 11/02/2007 | HDPE bottles of 60. Unit dose packages of 20. | Tentatively Approved | View Label | Lamivudine and Stavudine | Tablets | Mylan Laboratories Limited (FDF-1) Plot No. F/4 and F/12 Malegaon MIDC, Sinnar Nashik District, Maharashtra, India. 422113. | No | 2-Fixed Dose Combination | Yes | For Pediatric patients at least 12 years of age and weighing at least 30 kg. | Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). | Not Scored | Tentatively Approved 11/02/2007 | India | https://www.mylan.com/en/contact-mylan | 54 | No | |
| 022096 | Tentatively Approved | Lamivudine / Zidovudine Tablets Co-packaged with Efavirenz Tablets | 150 mg/300 mg + 600 mg | Strides Pharma Global PTE Limited. | NDA | Strides Pharma Science Limited | Strides Pharma Global PTE Limited. | 06/01/2007 | HDPE bottles of 60 Stavudine/Zidovudine tablets and 30 Efavirenz tablets. | Tentatively Approved | View Label | Lamivudine / Zidovudine co-packaged with Efavirenz | Tablets | Strides Pharma Science Limited No 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bengaluru, Karnataka, India. 562106 | Yes | 4-Fixed Dose Combination | Yes | For Pediatric patients at least 12 years of age and weighing at least 40 kg. | Store at 20 to 25° C (68 to 77° F). | 24 | Not Scored | Tentatively Approved 6/01/2007 | India | http://www.strides.com/contact.aspx | 45 | Yes |
| 022097 | Tentatively Approved | Stavudine / Lamivudine Tablets Co-packaged with Efavirenz Tablets | 40 mg/150 mg + 600 mg | Strides Pharma Global PTE Limited. | NDA | Strides Pharma Science Limited | Strides Pharma Global PTE Limited. | 06/01/2007 | HDPE bottles of 60 Stavudine/Lamivudine tablets and 30 Efavirenz tablets. | Tentatively Approved | View Label | Stavudine / Lamivudine Co-packaged with Efavirenz | Tablets | Strides Pharma Science Limited No 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bengaluru, Karnataka, India. 562106 | Yes | 4-Fixed Dose Combination | Yes | For Pediatric patients at least 12 years of age and weighing at least 60 kg. | Store at 20 to 25°C (68 to 77° F). | 15 | Not Scored | Tentatively Approved 6/01/2007 | India | http://www.strides.com/contact.aspx | 46 | No |
| 022141 | Approved | Lamivudine and Tenofovir Disoproxil Fumarate Tablets | 300 mg/300 mg | Mylan Laboratories Limited | NDA | Mylan Laboratories Limited | Mylan Specialty L.P. | 02/28/2018 | HDPE bottles of 30 and 90 containing desiccant, induction seal, and child-resistant closure | Approved | View Label | Lamivudine and Tenofovir Disoproxil Fumarate | Tablets | Mylan Laboratories Limited (FDF-2) Plot No. H-12 & H-13 MIDC, Waluj. Aurangabad, Maharashtra, India. 431136 | No | 2-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 35 kg. | Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). | 24 | Not Scored | Approved 2/28/2018 Tentatively Approved 9/12/2008 | India | https://www.mylan.com/en/contact-mylan | 73 | Yes |
| 022142 | Approved | Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets | 600 mg/300 mg/300 mg | Mylan Laboratories Limited | NDA | Mylan Laboratories Limited | Mylan Specialty L.P. | 03/22/2018 | HDPE bottle of 30. | Approved | View Label | Efavirenz, lamivudine, and tenofovir disoproxil fumarate | Tablets | Mylan Laboratories Limited (FDF-2) Plot No. H-12 & H-13 MIDC, Waluj. Aurangabad, Maharashtra, India. 431136 Mylan Laboratories Limited (FDF-3) Plot No. 11, 12 and 13, Indore Special Economic Zone Pharma Zone, Phase-II, Secot-III, Pithampur Dhar district, Madhya Pradesh, India. 454775. | No | 3-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 40 kg. | Store below 30°C (86°F). | 36 | Not Scored | Approved 3/22/2018 Tentatively Approved 9/03/2009 | India | https://www.mylan.com/en/contact-mylan | 102 | Yes |
| 022167 | Withdrawn | Lamivudine and Stavudine Tablets for Oral Suspension | 60 mg/12 mg, 30 mg/6 mg | Cipla Limited | NDA | Withdrawn | Lamivudine and Stavudine | Tablets for Oral Suspension | No | 2-Fixed Dose Combination | Yes | Not Scored | Withdrawn 2/23/2017 Tentatively Approved 6/19/2008 | https://www.cipla.com/en/contact-us.html | 70 | No | ||||||||||
| 022177 | Tentatively Approved | Lamivudine, Stavudine, and Nevirapine Tablets | 150 mg/30 mg/200 mg | Strides Pharma Global PTE Limited. | NDA | Strides Pharma Science Limited | Strides Acrolab Limited | 03/20/2008 | HDPE bottles of 60. | Tentatively Approved | View Label | Lamivudine, Stavudine, and Nevirapine | Tablets | Strides Pharma Science Limited No 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bengaluru, Karnataka, India. 562106 | No | 3-Fixed Dose Combination | Yes | For Pediatric patients at least 12 years of age and weighing at least 50 kg. | Store below 25°C. | 24 | Not Scored | Tentatively Approved 3/20/2008 | India | http://www.strides.com/contact.aspx | 65 | No |
| 022282 | Tentatively Approved | Atazanavir Sulfate and Ritonavir Tablets | 300 mg/100 mg | Mylan Laboratories Limited | NDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 11/18/2011 | HDPE bottles of 30, 90, and 120. | Tentatively Approved | View Label | Atazanavir Sulfate and Ritonavir | Tablets | Mylan Laboratories limited (FDF-1) Plot No. F/4 and F/12 Malegaon MIDC, Sinnar, Nashik District, Maharashtra India. 422113. | No | 2-Fixed Dose Combination | Yes | For Pediatric patients at least 6 years of age and weighing at least 40 kg. | Store film-coated tablets at 25°C (77°F); excursions permitted to 15-30°C (59 to86°F). | Not Scored | Tentatively Approved 11/18/2011 | India | https://www.mylan.com/en/contact-mylan | 136 | Yes | |
| 022293 | Withdrawn | Abacavir Sulfate Tablets | 60 mg | Aurobindo Pharma Limited | NDA | Withdrawn | Abacavir Sulfate | Tablets | No | Single | Yes | Not Scored | Withdrawn 8/7/2013 Tentatively Approved 9/12/2008 | https://www.aurobindousa.com/contact-us/ | 74 | No | ||||||||||
| 022294 | Withdrawn | Zidovudine Tablets | 60 mg | Aurobindo Pharma Limited | NDA | Withdrawn | Zidovudine | Tablets | No | Single | Yes | Not Scored | Withdrawn FR Effective 7/21/2017 Withdrawn 8/7/2013 Approved 7/23/2009 | https://www.aurobindousa.com/contact-us/ | 97 | No | ||||||||||
| 022295 | Tentatively Approved | Abacavir Sulfate and Lamivudine Tablets | 60 mg/30 mg | Aurobindo Pharma Limited | NDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 12/12/2008 | HDPE bottles of 30 and 60.Blister packs of 10 unit doses in cartons of 100 (10X10). | Tentatively Approved | View Label | Abacavir Sulfate and Lamivudine | Tablets | Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090 | No | 2-Fixed Dose Combination | Yes | For Pediatric patients at least 3 months of age. | Store at 25 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 89°F). | 24 | Scored | Tentatively Approved 19/12/2008 | India | https://www.aurobindousa.com/contact-us/ | 79 | Yes |
| 022296 | Withdrawn | Lamivudine and Zidovudine Tablets | 30 mg/60 mg | Aurobindo Pharma Limited | NDA | Withdrawn | Lamivudine and Zidovudine | Tablets | No | 2-Fixed Dose Combination | Yes | Not Scored | Withdrawn 7/12/2019 Tentatively Approved 7/23/2009 | https://www.aurobindousa.com/contact-us/ | 98 | No | ||||||||||
| 022297 | Withdrawn | Efavirenz Tablets | 100 mg | Aurobindo Pharma Limited | NDA | Withdrawn | Efavirenz | Tablets | No | Single | Yes | Not Scored | Withdrawn 8/7/2013 Tentatively Approved 12/12/2008 | https://www.aurobindousa.com/contact-us/ | 78 | No | ||||||||||
| 022299 | Withdrawn | Nevirapine Tablets for Oral Suspension | 50 mg | Aurobindo Pharma Limited | NDA | Withdrawn | Nevirapine | Tablet for Oral Suspension | No | Single | Yes | Scored | Withdrawn 8/25/2023; TA'd 2/24/2010 | India | https://www.aurobindousa.com/contact-us/ | 108 | No | |||||||||
| 022342 | Withdrawn | Lamivudine, Nevirapine, and Stavudine Tablets | 150 mg/200 mg/30 mg, 150 mg/200 mg/40 mg | Emcure Pharmaceuticals Limited | NDA | Withdrawn | Lamivudine, Nevirapine, and Stavudine | Tablets | No | 3-Fixed Dose Combination | Yes | Not Scored | Withdrawn 4/13/2018 Tentatively Approved 7/16/2009 | https://emcure.com/contactus | 96 | No | ||||||||||
| 022343 | Approved | Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets | 600 mg/300 mg/300 mg | Aurobindo Pharma Limited | NDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 08/15/2018 | HDPE bottles of 30 and 90 count with heat sealed liner, desiccant, and child resistant caps. | Approved | View Label | Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate | Tablets | APL Healthcare Limited, Unit-IV Plot No.16, APIIC Multi Product SEZ, Menakuru, Naidupeta, S.P.S.R Nellore, Andhra Pradesh, 524421 India Aurobindo Pharma Limited, Unit-VII Sy.No. 411/P, 425/P, 434/P, 435/P & 458/P, Plot No. S1 (Part) SEZ (Pharma), TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabub Nagar (District), Mahabub Nagar, Telangana -509302, India | No | 3-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 40 kg. | Store below 30°C (86°F). | 36 | Not Scored | Approved 8/15/2018 Tentatively Approved 6/26/2013 | India | https://www.aurobindousa.com/contact-us/ | 161 | Yes |
| 022344 | Approved | Lamivudine and Tenofovir Disoproxil Fumarate Tablets | 300 mg/300 mg | Aurobindo Pharma Limited | NDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 05/15/2018 | HDPE bottle of 30 with an induction seal, desiccant, & child-resistant cap. | Approved | View Label | Lamivudine and Tenofovir Disoproxil Fumarate | Tablets | Aurobindo Pharma Limited Unit-VII, Sy.No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No. S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India.509302. | No | 2-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 35 kg. | Store below 30°C (86°F). | 24 | Not Scored | Approved 5/15/2018 Tentatively Approved 1/07/2011 | India | https://www.aurobindousa.com/contact-us/ | 124 | No |
| 022346 | Withdrawn | Stavudine, Lamivudine, and Nevirapine Tablets | 30 mg/150 mg/200 mg, 40 mg/150 mg/200 mg | Pharmacare Limited | NDA | Withdrawn | Stavudine, Lamivudine, and Nevirapine | Tablets | No | 3-Fixed Dose Combination | Yes | Not Scored | Withdrawn 6/15/2016 Tentatively Approved 2/27/2009 | http://www.pharmacarelimited.com/contactus | 82 | No | ||||||||||
| 022347 | Withdrawn | Stavudine and Lamivudine Tablets | 30 mg/150 mg, 40 mg/150 mg | Pharmacare Limited | NDA | Withdrawn | Stavudine and Lamivudine | Tablets | No | 2-Fixed Dose Combination | Yes | Not Scored | Withdrawn 6/15/2016 Tentatively Approved 3/18/2009 | http://www.pharmacarelimited.com/contactus | 86 | No | ||||||||||
| 022356 | Tentatively Approved | Lamivudine and Zidovudine Tablets Co - packaged with Nevirapine Tablets | 150 mg/300 mg + 200 mg | Hetero Labs Limited Unit III | NDA | Hetero Labs Limited Unit III | Hetero Labs Limited Unit III | 05/07/2009 | Blister packs of 10 unit does packed in cartons of 6 (6X10). | Tentatively Approved | View Label | Lamivudine and Zidovudine Tablets Co - packaged with Nevirapine Tablets | Tablets | Hetero Labs Limited III Plot No. 22-110, Part-II, IDA, Jeedimetla Hyderabad, Telangana, India. 500055. | Yes | 4-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 30 kg. | Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). | 24 | Not Scored | Tentatively Approved 5/07/2009 | India | https://www.heteroworld.com/contact-us.php | 92 | No |
| 022420 | Tentatively Approved | Efavirenz Tablets | 200 mg | Strides Pharma Global PTE Limited | NDA | Strides Pharma Science Limited | Strides Pharma Global PTE Limited | 02/12/2010 | HDPE bottle of 90. | Tentatively Approved | View Label | Efavirenz | Tablets | Strides Pharma Science Limited No 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bengaluru, Karnataka, India. 562106 | No | Single | Yes | For Pediatric patients at least 3 years of age and weighing at least 10 kg. | Store at 20 to 25° C (68 to 77° F). | 24 | Scored | Tentatively Approved 2/12/2010 | India | http://www.strides.com/contact.aspx | 107 | Yes |
| 022459 | Tentatively Approved | Lamivudine and Tenofovir Disoproxil Fumarate Tablets | 300 mg/300 mg | Hetero Labs Limited Unit III | NDA | Hetero Labs Limited | Hetero Labs Limited Unit III and Unit- V | 11/05/2009 | HDPE bottles of 30, 60 and 100 with child-resistant/continuous thread plastic caps, pulp liner, filler, and desiccant.HDPE bottles of 500 with continuous thread plastic caps, pulp liner, filler and desiccant. | Tentatively Approved | View Label | Lamivudine and Tenofovir Disoproxil Fumarate | Tablets | HETERO LABS LIMITED UNIT-III 22-110, Industrial Development Area Jeedimetla, Hyderabad, Telanagana, India. 500055 HETERO LABS LIMITED UNIT V Sy. No.: 439, 440, 441 & 458, TSIIC Formulation SEZ Polepally Village, Jadcherla Mandal Mahabubnagar, Telangana, India. 509301 | No | 2-Fixed Dose Combination | Yes | For Pediatric patients at least 16 years of age and weighing at least 35 kg. | Store below 30°C. | 24 | Not Scored | Tentatively Approved 11/05/2009 | India | https://www.heteroworld.com/contact-us.php | 103 | Yes |
| 022461 | Tentatively Approved | Efavirenz Tablets | 50 mg, 100 mg, 200 mg | Mylan Laboratories Limited | NDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 11/24/2009 | HDPE bottles of 30 or 90 with induction seal and desiccant. | Tentatively Approved | View Label | Efavirenz | Tablets | Mylan Laboratories Limited (FDF-1) Plot No. F-4 and F-12 Malegaon M.I.D.C., Sinnar Nashik District, Maharashtra, India. 422113 | No | Single | Yes | For Pediatric patients at least 3 years of age and weighing at least 10 kg. | Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). | 24 | Not Scored | Tentatively Approved 11/24/2009 | India | https://www.mylan.com/en/contact-mylan | 105 | Yes |
| 022464 | Tentatively Approved | Lamivudine, Nevirapine, and Zidovudine Tablets | 150 mg/200 mg/300 mg | Strides Pharma Global PTE Limited | NDA | Strides Pharma Science Limited | Strides Pharma Global PTE Limited | 12/22/2009 | HDPE bottle of 60. | Tentatively Approved | View Label | Lamivudine, Nevirapine, and Zidovudine | Tablets | Strides Pharma Science Limited No 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bengaluru, Karnataka, India. 562106 | No | 3-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 30 kg. | Store at 20 to 25°C (68 to 77°F). | 24 | Not Scored | Tentatively Approved 12/22/2009 | India | http://www.strides.com/contact.aspx | 106 | Yes |
| 022479 | Withdrawn | Lamivudine and Stavudine Tablets | 150 mg/30 mg | Hetero Labs Limited Unit III | NDA | Withdrawn | Lamivudine and Stavudine | Tablets | No | 2-Fixed Dose Combination | Yes | Not Scored | Withdrawn 11/3/2017 Tentatively Approved 5/17/2010 | https://www.heteroworld.com/contact-us.php | 112 | No | ||||||||||
| 022537 | Withdrawn | Lamivudine, Nevirapine, and Stavudine Tablets | 150 mg/200 mg/30 mg | Macleods Pharmaceuticals Limited | NDA | Withdrawn | Lamivudine, Nevirapine, and Stavudine | Tablets | No | 3-Fixed Dose Combination | Yes | Not Scored | Withdrawn 10/10/2017 Tentatively Approved 8/30/2010 | http://www.macleodspharma.com/UnitedStates.asp | 116 | No | ||||||||||
| 022541 | Withdrawn | Lamivudine and Stavudine Tablets | 150 mg/30 mg | Macleods Pharmaceuticals Limited | NDA | Withdrawn | Lamivudine and Stavudine | Tablets | No | 2-Fixed Dose Combination | Yes | Not Scored | Withdrawn 10/10/2017 Tentatively Approved 8/5/2010 | http://www.macleodspharma.com/UnitedStates.asp | 114 | No | ||||||||||
| 022547 | Tentatively Approved | Abacavir Sulfate Tablets for Oral Suspension Dispersible tablets | 60 mg | Cipla Limited | NDA | Cipla Limited | Cipla Limited | 03/04/2011 | HDPE bottles of 60 with desiccant, heat-sealed liner, and Non-CRC or CRC caps | Tentatively Approved | View Label | Abacavir Sulfate | Tablets for Oral Suspension | Cipla Limited, A-33 MIDC, Patalganga Industrial Area, District: Raigad Patalganga, Maharashtra, India. 410220 | No | Single | Yes | For Pediatric patients at least 3 months of age. | Store at 25°C (77°F); excursions permitted to 15 to 30°C (59° to 86°F). | 24 | Scored | Tentatively Approved 3/04/2011 | India | https://www.cipla.com/en/contact-us.html | 128 | Yes |
| 077167 | Approved | Didanosine Capsules | 200 mg, 250 mg, 400 mg | Barr Laboratories Limited | ANDA | Barr Laboratories Inc. | Teva Pharmaceuticals USA | 12/03/2004 | HDPE bottles of 30. | Approved | View Label | Didanosine | Delayed Release Capsule | Barr Laboratories Inc. 2150 Perrowville Road Forest, VA, USA, 24551. | No | Single | Yes | For Pediatric patients at least 6 years of age, weighing at least 20 kg, and for whom a solid dosage form is appropriate. | Store at 20 to 25°C (68 to 77°F). | 24 | Not Scored | Approved 12/03/2004 | USA | https://www.tevagenerics.com/contact-us | 1 | No |
| 077267 | Approved | Zidovudine Tablets | 300 mg | Aurobindo Pharma Limited | ANDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 09/19/2005 | HDPE bottle of 60.Blister packs of 60 unit doses in packs of 10 (6X10). | Approved | View Label | Zidovudine | Tablets | Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090. Aurobindo Pharma Limited Unit-VII, Survey No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No.S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India. 509302. | No | Single | Yes | For Pediatric patients at least 4 weeks of age and for whom a solid dosage form is appropriate. | Store at 20 to 25°C (68 to 77°F). | Not Scored | Approved 9/19/2005 Tentatively Approved 8/25/2005 | India | http://www.aurobindousa.com/contact-us/ | 11 | No | |
| 077268 | Approved | Zidovudine Oral Solution | 10 mg/mL | Aurobindo Pharma Limited | ANDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 09/19/2005 | HDPE Bottles 240 mL | Approved | View Label | Zidovudine | Oral Solution | Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090. | No | Single | Yes | For Pediatric patients at least 4 weeks of age. | Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). | 24 | Not Scored | Approved 9/19/2005 TA'd 09/07/2005 | India | http://www.aurobindousa.com/contact-us/ | 12 | Yes |
| 077275 | Withdrawn | Didanosine Tablets | 100 mg, 150 mg, 200 mg | Aurobindo Pharma Limited | ANDA | Withdrawn | Didanosine | Tablets / Chewable / Dispersible / Buffered | No | Single | Yes | Not Scored | Withdrawn FR Effective 7/21/2017 Withdrawn 7/21/2014 Approved 8/14/2012 Tentatively Approved 7/10/2006 | https://www.aurobindousa.com/contact-us/ | 25 | No | ||||||||||
| 077327 | Withdrawn | Zidovudine Tablets | 300 mg | Sun Pharmaceutical Industries Ltd. | ANDA | Withdrawn | Zidovudine | Tablets | No | Single | Yes | Not Scored | Withdrawn FR Effective 9/21/2012 Withdrawn 5/17/2012 Approved 9/19/2005 Tentatively Approved 7/13/2005 | https://www.sunpharma.com/contact/usa | 10 | No | ||||||||||
| 077357 | Withdrawn | Lamivudine Tablets | 150 mg | Sun Pharmaceutical Industries Ltd. | ANDA | Withdrawn | Lamivudine | Tablets | No | Single | Yes | Not Scored | Withdrawn 1/20/2016 Tentatively Approved 5/27/2005 | https://www.sunpharma.com/contact/usa | 3 | No | ||||||||||
| 077411 | Approved | Lamivudine and Zidovudine Tablets | 150 mg/300 mg | Cipla Limited | ANDA | Cipla Limited | Cipla Limited | 09/07/2019 | HDPE bottles of 30, 60, and 1000. Unit dose blister pack in boxes of 100 tablets (10X10). | Approved | View Label | Lamivudine and Zidovudine | Tablets | Cipla Limited, L139 to L146 (Unit III and IV), L147 to L-147/1 (Unit VII). Verna Industrial Area, Verna, Salcette, Goa 403 722, India (IND) Cipla Limited, Plot No. A-42, Patalganga (Unit II) Industrial Area, Patalganga, Raigad, Maharashtra 410 220, India (IND) | No | 2-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 30 kg. | Store between 20 and 25°C (68 and 77°F). | 24 | Scored | Approved 9/7/2018 Tentatively Approved 9/13/2006 | India | https://www.cipla.com/en/contact-us.html | 30 | Yes |
| 077429 | Withdrawn | Nevirapine Tablets | 200 mg | Sun Pharmaceutical Industries Ltd. | ANDA | Withdrawn | Nevirapine | Tablets | No | Single | Yes | Not Scored | Withdrawn 1/20/2016 Tentatively Approved 6/20/2005 | https://www.sunpharma.com/contact/usa | 4 | No | ||||||||||
| 077464 | Approved | Lamivudine Tablets | 150 mg, 300 mg | Aurobindo Pharma Limited | ANDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 11/21/2016 | HDPE bottle of 60 and cartons of 60 unit doses in 10 unit dose blister packs (6X10) of the 150 mg strength. HDPE bottle of 30 and cartons of 30 unit doses in 10 unit dose blister packs (3X10) of the 300 mg strength. | Approved | View Label | Lamivudine | Tablets | Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090 Aurobindo Pharma Limited Unit-VII, Survey No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No.S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India. 509302. | No | Single | Yes | For Pediatric patients weighing at least 14 kg and for whom a solid dosage form is appropriate. | Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). | 36 | Not Scored | Approved 11/21/2016 Tentatively Approved 6/15/2005 | India | http://www.aurobindousa.com/contact-us/ | 5 | No |
| 077521 | Approved | Nevirapine Tablets | 200 mg | Aurobindo Pharma Limited | ANDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 05/22/2012 | HDPE bottle of 60.Cartons of 60 unit doses in 10 unit dose blister packs (6X10). | Approved | View Label | Nevirapine | Tablets | Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090 Aurobindo Pharma Limited Unit-VII, Survey No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No.S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India. 509302. | No | Single | Yes | For Pediatric patients at least 15 days of age. | Store at 20 to 25° C (68 to 77° F); excursions permitted to 15 to 30° C (59 to 86° F). | Scored | Approved 05/22/2012 Tentatively Approved 6/20/200 | India | http://www.aurobindousa.com/contact-us/ | 6 | Yes | |
| 077558 | Approved | Lamivudine and Zidovudine Tablets | 150 mg/300 mg | Aurobindo Pharma Limited | ANDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 05/05/2017 | HDPE bottle of 60. Cartons of 60 unit doses in 10 unit dose blister packs (6X10). | Approved | View Label | Lamivudine and Zidovudine | Tablets | Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090 Aurobindo Pharma Limited Unit-VII, Survey No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No.S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India. 509302. | No | 2-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 30 kg and for whom a solid dosage form is appropriate. | Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). | Scored | Approved 5/5/2017 Tentatively Approved 7/07/2005 | India | http://www.aurobindousa.com/contact-us/ | 9 | No | |
| 077672 | Withdrawn | Stavudine Capsules | 15 mg, 20 mg, 30 mg, 40 mg | Aurobindo Pharma Limited | ANDA | Withdrawn | Stavudine | Capsules | No | Single | Yes | Not Scored | Withdrawn FR Effective 1/11/2021 Withdrawn 09/18/2020 Approved 12/29/2008 Tentatively Approved 7/1/2005 | https://www.aurobindousa.com/contact-us/ | 8 | No | ||||||||||
| 077672 | Withdrawn | Stavudine Capsules | 15 mg, 20 mg | Aurobindo Pharma Limited | ANDA | Withdrawn | Stavudine | Capsules | No | Single | Yes | Not Scored | Withdrawn FR Effective 1/11/2021 Withdrawn 09/18/2020 Approved 12/29/2008 Tentatively Approved 7/1/2005 | https://www.aurobindousa.com/contact-us/ | 23 | No | ||||||||||
| 077673 | Approved | Efavirenz Tablets | 600 mg | Aurobindo Pharma Limited | ANDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 09/21/2018 | HDPE bottle packs of 30 with child resistant closure and blister packs of 10 (3x 10's). | Approved | View Label | Efavirenz | Tablets | Unit-III, Sy. No.313 & 314, Bachupally, Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, 500090, India Unit-VII, Sy.No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No.S1 (Part) SEZ (Pharma), TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, 509302 India | No | Single | Yes | For Pediatric patients at least 3 months of age and weighing at least 3.5kgs. | Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F) | 36 | Not Scored | Approved 9/21/2018 Tentatively Approved 6/24/2005 | India | http://www.aurobindousa.com/contact-us/ | 7 | Yes |
| 077695 | Approved | Lamivudine Oral Solution | 10 mg/mL | Aurobindo Pharma Limited | ANDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 11/21/2016 | HDPE bottle of 240mL with child-resistant closure. | Approved | View Label | Lamivudine | Oral Solution | Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090. | No | Single | Yes | For Pediatric patients at least 3 months of age. | Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). | 24 | Not Scored | Approved 11/21/2016 TA'd 11/04/2005 | India | http://www.aurobindousa.com/contact-us/ | 13 | Yes |
| 077702 | Approved | Nevirapine Oral Suspension | 50 mg/5 mL | Aurobindo Pharma Limited | ANDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 05/22/2012 | HDPE bottles of 100mL and 240mL. | Approved | View Label | Nevirapine | Oral Suspension | Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090. | No | Single | Yes | For Pediatric patients at least 15 days of age. | Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C(59° to 86°F) | 36 | Not Scored | Approved 5/22/2012; TA'd 12/29/2005 | India | http://www.aurobindousa.com/contact-us/ | 15 | Yes |
| 077774 | Withdrawn | Stavudine powder for Oral Solution | 1 mg/mL | Aurobindo Pharma Limited | ANDA | Withdrawn | Stavudine | Oral Solution | No | Single | Yes | Not Scored | Withdrawn FR Effective 7/21/2017 Withdrawn 7/21/2014 Approved 12/29/2008 Tentatively Approved 12/21/2005 | http://www.aurobindousa.com/contact-us/ | 14 | No | ||||||||||
| 077844 | Approved | Abacavir Sulfate Tablets | 300 mg | Aurobindo Pharma Limited | ANDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 12/17/2012 | HDPE bottle of 60. | Approved | View Label | Abacavir Sulfate | Tablets | Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090. Aurobindo Pharma Limited Unit-VII, Sy.No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No.S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India. 509302. | No | Single | Yes | For Pediatric patients at least 3 months of age, weighing at least 14 kg, and for whom a solid dosage form is appropriate. | Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). | 36 | Scored | Approved 12/17/2012 Tentatively Approved 5/17/2006 | India | http://www.aurobindousa.com/contact-us/ | 18 | Yes |
| 077916 | Tentatively Approved | Efavirenz Tablets | 600 mg | Cipla Limited | ANDA | Cipla Limited | Cipla Limited | 05/24/2006 | HDPE bottles 30 and 500. Boxes of 60 unit dose tablets in blister packs of 10 (6X10). | Tentatively Approved | View Label | Efavirenz | Tablets | Cipla limited, Goa Cipla Limited,L-139 to L-146, Verna Industrial Estate. Verna, Goa, India. 403722. Cipla Ltd., Goa Plot no. L-147 to L-147-1, Verna Industrial Estate, Verna Salcette. Verna, Goa, India. 403722. | No | Single | Yes | For Pediatric patients weighing at least 40 kg. | Store at 20°C-25°C (68°F - 77°F). | Not Scored | Tentatively Approved 5/24/2006 | India | https://www.cipla.com/en/contact-us.html | 20 | Yes | |
| 077950 | Approved | Abacavir Sulfate Oral Solution | 20 mg/mL | Aurobindo Pharma Limited | ANDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. Rising Pharmaceutical Inc. | 03/14/2018 | HDPE containers of 240 mL with child-resistant closure and tamper evident seal. | Approved | View Label | Abacavir Sulfate | Oral Solution | Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090 | No | Single | Yes | For Pediatric patients at least 3 months of age. | Store at 20 to 25°C (68 to 77°F). DO NOT FREEZE. May be refrigerated | 24 | Not Scored | Approved 3/14/2018 Tentatively Approved 6/27/2006 | India | https://www.aurobindousa.com/contact-us/ | 22 | Yes |
| 077956 | Approved | Nevirapine Tablets | 200 mg | Cipla Limited | ANDA | Cipla Limited | Cipla Limited | 05/22/2012 | HDPE bottle of 60 and 1000. | Approved | View Label | Nevirapine | Tablets | Cipla Limited Goa Plot no. L-139 to L-146 (Unit III), L-147 to L-147-1 (Unit VII) and L-147/4 (Unit X) Verna Industrial Estate Verna, Goa, India. 403722. | No | Single | Yes | For Pediatric patients at least 15 days of age. | Store at 20°C-25°C (68°F-77°F). | 36 | Scored | Approved 5/22/2012 Tentatively Approved 5/19/2006 | India | https://www.cipla.com/en/contact-us.html | 19 | Yes |
| 077980 | Tentatively Approved | Lamivudine Oral Solution | 10 mg/mL | Cipla Limited | ANDA | Cipla Limited | Cipla Limited | 06/22/2006 | HDPE bottles 100 mL and 240 mL. | Tentatively Approved | View Label | Lamivudine | Oral Solution | Cipla limited Plot No. 9, 10, 15 (Unit I), Indore SEZ District Dhar, Madhya Pradesh, India. 454775. | No | Single | Yes | For Pediatric Patients at least 3 months of age. | Store at 20°C - 25°C (68°F - 77°F);excursions permitted to 15°C - 30°C (59°F - 86°F). | 18 | Not Scored | Tentatively Approved 6/22/2006 | India | https://www.cipla.com/en/contact-us.html | 21 | Yes |
| 077981 | Approved | Zidovudine Oral Solution | 50 mg/5 mL | Cipla Limited | ANDA | Cipla Limited | Cipla Limited | 06/26/2008 | HDPE bottle 240 mL. | Approved | View Label | Zidovudine | Oral solution | Cipla limited L-139 to L-146, Verna Industrial Estate Verna, Salcette, Goa, India. 403722. Cipla Limited Unit I, Plot No.9, 10 & 15; Indore Special Economic Zone, Phase II, Pithampur, Madhya Pradesh, India. 454775. | No | Single | Yes | For Pediatric patients at least 6 weeks of age. | Store at 20 to 25°C (68 to 77 °F). | 24 | Not Scored | Approved 6/26/2008 | India | https://www.cipla.com/en/contact-us.html | 71 | Yes |
| 078030 | Approved | Stavudine Oral Solution | 1 mg/mL | Cipla Limited | ANDA | Cipla Limited | Cipla Limited | 03/20/2009 | HDPE bottles 200ml with child-resistant closure. | Approved | View Label | Stavudine | Oral Solution | Cipla Limited, Goa Unit IX, M61, M-62 and M63, Verna Industrial estate Verna, Salcette, Goa, India. 403722. | No | Single | Yes | Indicated for all Pediatric patients. | Stavudine for oral solution should be protected from excessive moisture and stored in tightly closed containers at 20°C-25°C (68°F-77°F).After constitution, store tightly closed containers of Stavudine for Oral Solution in a refrigerator, 2°C to 8°C (36 | 24 | Not Scored | Approved 03/20/2009 TA'd 10/29/2007 | India | https://www.cipla.com/en/contact-us.html | 53 | Yes |
| 078064 | Approved | Efavirenz Capsules | 50 mg, 100 mg, 200 mg | Aurobindo Pharma Limited | ANDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 12/15/2017 | HDPE bottles of 30 and blister packs of 30 unit dose capsules (3X10) for all dosage strengths. HDPE bottles of 90 and blister packs of 90 unit dose tablets (9X10) of 200mg capsules. | Approved | View Label | Efavirenz | Capsules | Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090. Aurobindo Pharma Limited Unit-VII, Sy.No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No.S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India. 509302. | No | Single | Yes | For Pediatric patients at least 3 months of age and weighing at least 3.5 kg. | Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). | 36 | Not Scored | Approved 12/15/2017 Tentatively Approved 12/19/2006 | India | https://www.aurobindousa.com/contact-us/ | 34 | No |
| 078112 | Withdrawn | Didanosine Powder for Oral Solution | 10 mg/mL | Aurobindo Pharma Limited | ANDA | Withdrawn | Didanosine | Powder for Oral Solution | No | Single | Yes | Not Scored | Withdrawn FR Effective 7/21/2017 Withdrawn 7/21/2014 Approved 3/8/2007 Tentatively Approved 10/5/2006 | https://www.aurobindousa.com/contact-us/ | 31 | No | ||||||||||
| 078119 | Approved | Abacavir Sulfate Tablets | 300 mg (base) | Cipla Limited | ANDA | Cipla Limited | Cipla USA, Inc. | 11/21/2017 | HDPE bottle of 60. | Approved | View Label | Abacavir Sulfate | Tablets | Cipla limited, Patalganga Cipla Limited, Unit I and II, A-33, A-42, MIDC, Dist: Raigad, Patalganga, Maharashtra, India. 410220. | No | Single | Yes | For Pediatric patients at least 3 months of age. | Store at 20 to 25°C (68 to 77°F). | 24 | Scored | Approved 11/21/2017 Tentatively Approved 11/06/06 | India | https://www.cipla.com/en/contact-us.html | 32 | Yes |
| 078128 | Approved | Zidovudine Capsules | 100 mg | Aurobindo Pharma Limited | ANDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. Lucid Pharma LLC | 03/27/2006 | HDPE bottle of 100 Cartons of 100 unit dose tablets in blister packs of 10 (10X10). | Approved | View Label | Zidovudine | Capsules | Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090. Aurobindo Pharma Limited Unit-VII, Sy.No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No.S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India. 509302. | No | Single | Yes | For Pediatric patients at least 4 weeks of age and weighing at least 4 kg. | Store at 20 to 25°C (68 to 77°F). | Not Scored | Approved 3/27/2006 | India | http://www.aurobindousa.com/contact-us/ | 17 | No | |
| 078195 | Approved | Nevirapine Tablets | 200 mg | Strides Pharma Global PTE Limited. | ANDA | Strides Pharma Science Limited | Strides Pharma Inc. | 05/22/2012 | HDPE bottle of 60. | Approved | View Label | Nevirapine | Tablets | Strides Pharma Science Limited No 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bengaluru, Karnataka, India. 562106 | No | Single | Yes | For Pediatric patients at least 15 days of age. | Store below 30°C. Protect from light. Store in a safe place out of the reach of children. | 36 | Scored | Approved 5/22/2012 Tentatively Approved 8/11/2006 | India | http://www.strides.com/contact.aspx | 27 | Yes |
| 078256 | Tentatively Approved | Stavudine Capsules | 30 mg, 40 mg | Strides Pharma Global PTE Limited. | ANDA | Strides Pharma Science Limited | Strides Pharma Global PTE Limited. | 08/28/2006 | HDPE Bottles of 60's | Tentatively Approved | View Label | Stavudine | Capsules | Strides Pharma Science Limited No 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bengaluru, Karnataka, India. 562106 | No | Single | Yes | Indicated for all Pediatric patients. | Store in tightly closed containers at 25°C (77° F); Excursions permitted from 15 to 30°C (59 and 86°F). | 24 | Not Scored | Tentatively Approved 8/28/2006 | India | http://www.strides.com/contact.aspx | 29 | No |
| 078348 | Withdrawn | Abacavir Sulfate Oral Suspension | 20 mg/mL | Cipla Limited | ANDA | Withdrawn | Abacavir Sulfate | Oral Solution | No | Single | Yes | Not Scored | Withdrawn 05/18/2016 Tentatively Approved 2/16/2011 | https://www.cipla.com/en/contact-us.html | 125 | No | ||||||||||
| 078349 | Approved | Zidovudine Capsules | 100 mg | Cipla Limited | ANDA | Cipla Limited | Cipla Limited | 05/23/2007 | HDPE bottles of 100 and 1000. | Approved | View Label | Zidovudine | Capsules | Cipla Limited Plot No L-147 to L-147 (Unit VII),Plot No L139-L146 (Unit IV),and L-147-4 (Unit X) Verna Industrial Estate, Verna, Goa, India. 403722. | No | Single | Yes | For Pediatric patients at least 4 weeks of age and weighing at least 4 kg. | Store at 20°C-25°C (68°F-77°F). | 24 | Not Scored | Approved 5/23/2007 | India | https://www.cipla.com/en/contact-us.html | 44 | Yes |
| 078509 | Approved | Efavirenz Tablets | 600 mg | Strides Pharma Global PTE Limited. | ANDA | Strides Pharma Science Limited | Strides Pharma Global PTE Limited. | 03/26/2007 | HDPE bottles of 30. | Approved | View Label | Efavirenz | Tablets | Strides Pharma Science Limited No 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bengaluru, Karnataka, India. 562106 | No | Single | Yes | For Pediatric patients at least 3 months of age and weighing at least 3.5 kg. | Store at 25°C (77°F) excursions permitted to 15–30°C (59–86°F). | 36 | Not Scored | Approved 6/17/2021 Tentatively Approved 3/26/2007 | India | http://www.strides.com/contact.aspx | 41 | Yes |
| 078545 | Approved | Lamivudine Tablets | 150 mg, 300 mg | Mylan Laboratories Limited | ANDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 03/05/2019 | HDPE bottle of 60. Cartons of 60 unit dose blister packs (6X10). | Approved | View Label | Lamivudine | Tablets | Mylan Laboratories Limited (FDF-1) Plot No. F/4 and F/12 Malegaon MIDC, Sinnar Nashik Dist., Maharashtra, 422-113 India | No | Single | Yes | For Pediatric patients weighing at least 14 kg and for whom a solid dosage form is appropriate. | Store at 20 to 25°C (68 to 77°F). | Not Scored | Approved 3/5/2019 Tentatively Approved 3/19/2007 | India | https://www.mylan.com/en/contact-mylan | 40 | No | |
| 078584 | Approved | Nevirapine Tablets | 200 mg | Hetero Labs Limited Unit III | ANDA | Hetero Labs Limited Unit III | Camber Pharmaceuticals, Inc. | 05/22/2012 | HDPE bottles of 60, 100, 500, and 1000 tablets. | Approved | View Label | Nevirapine | Tablets | Hetero Labs Limited Unit III Plot No. 22-110, Part-II, Industrial Development Area Jeedimetla, Hyderabad, Telangana, India 500055. | No | Single | Yes | For Pediatric patients at least 15 days of age. | Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). | Scored | Approved 05/22/2012 TA'd 8/13/2007 | India | https://www.heteroworld.com/contact-us.php | 50 | Yes | |
| 078587 | Withdrawn | Stavudine Capsules | 40 mg | Emcure Pharmaceuticals Limited | ANDA | Withdrawn | Stavudine | Capsules | No | Single | Yes | Not Scored | Withdrawn 04/13/2018 Tentatively Approved 12/12/2007 | https://emcure.com/contactus | 57 | No | ||||||||||
| 078644 | Approved | Nevirapine Tablets | 200 mg | Prinston Pharmaceutical Inc. | ANDA | Zhejiang Huahai Pharmaceutical Co., Ltd. | Breckenridge Pharmaceutical, Inc. | 05/22/2012 | HDPE bottle of 60. | Approved | View Label | Nevirapine | Tablets | Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang, China. 317024. | No | Single | Yes | For Pediatric patients at least 15 days of age. | Store at 20°C-25°C (68°F-77°F), excursion permitted to 15°C-30°C (59°F-86°F). | 36 | Scored | Approved 5/22/2012 Tentatively Approved 7/10/2007 | China | http://www.prinstonpharm.com/col.jsp?id=164 | 47 | No |
| 078742 | Tentatively Approved | Abacavir Sulfate Tablets | 300 mg | Mylan Laboratories Limited | ANDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 04/05/2007 | HDPE bottles of 60. Blister packs of 60 unit dose tablets (6X10). | Tentatively Approved | View Label | Abacavir Sulfate | Tablets | Mylan Laboratories Limited (FDF-1) Plot No. F/4 and F/12 Malegaon MIDC, Sinnar Nashik District, Maharashtra, India. 422113. Mylan Laboratories Limited (FDF-3) Plot No. 11, 12 & 13, Indore Special Economic Zone Pharma Zone, Phase - II, Sector - III, Pithampur District Dhar, Madhya Pradesh, India. 454775. | No | Single | Yes | For Pediatric patients at least 3 months of age. | Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). | Not Scored | Tentatively Approved 4/05/2007 | India | https://www.mylan.com/en/contact-mylan | 42 | Yes | |
| 078775 | Approved | Stavudine Capsules | 30 mg, 40 mg | Mylan Laboratories Limited | ANDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 01/05/2009 | HDPE bottles of 60. | Approved | View Label | Stavudine | Capsules | Mylan Laboratories Limited (FDF-1) Plot No. F/4 and F/12 Malegaon MIDC, Sinnar Nashik District, Maharashtra, India. 422113. | No | Single | Yes | Indicated for all Pediatric patients. | Store at 25°C (77°F); excursions permitted to 15 to 30°C (59° to 86°F). | 24 | Not Scored | Approved 1/05/2009 Tentatively Approved 4/23/2007 | India | https://www.mylan.com/en/contact-mylan | 43 | No |
| 078785 | Tentatively Approved | Atazanavir Sulfate Capsules | 100 mg, 150 mg, 200 mg | Emcure Pharmaceuticals Limited | ANDA | Emcure Pharmaceuticals Limited | Emcure Pharmaceuticals Limited | 02/04/2008 | HDPE bottles of 60.60 unit dose capsules in strips of 6 (6X10). | Tentatively Approved | View Label | Atazanavir Sulfate | Capsules | Emcure Pharmaceuticals Limited Plot No. P-2, I.T.B.T. Park, Phase-II, MIDC, Hinjawadi Pune, Maharashtra, India. 411057. | No | Single | Yes | For Pediatric patients at least 6 years of age and weighing at least 15 kg. | Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F). | 36 | Not Scored | Tentatively Approved 2/04/2008 | India | https://emcure.com/contactus | 60 | Yes |
| 078800 | Approved | Tenofovir Disoproxil Fumarate Tablets | 300 mg | Cipla Limited | ANDA | Cipla Limited | Cipla USA, Inc. | 01/26/2018 | HDPE bottles of 30 with desiccant and child-resistant closure.HDPE bottles of 1000 with desiccant, sanicoil, and with non child-resistant closure. | Approved | View Label | Tenofovir Disoproxil Fumarate | Tablets | Cipla Limited, Unit VII, L139 to L146,S-103toS-105,S-107toS-112,L147toL-147/1/2/3/4,L-138,L-150,S-116,M-61,62,63 Verna Industrial Estate, Verna, Salcette, Goa, India. 403722. | No | Single | Yes | For Pediatric patients at least 2 years of age, weighing at least 35 kg, and for whom a solid dosage form is appropriate. | Store at 25°C (77°F), excursions permitted between 15 to 30°C (59 to 86°F). | 24 | Not Scored | Approved 1/26/2018 Tentatively Approved 4/29/2009 | India | https://www.cipla.com/en/contact-us.html | 91 | Yes |
| 078850 | Tentatively Approved | Lamivudine Tablets | 150 mg, 300 mg | Hetero Labs Limited Unit III | ANDA | Hetero Labs Limited Unit III | Hetero Labs Limited Unit III | 01/29/2008 | HDPE bottle of 60 with child resistant closure of 150 mg strength. HDPE bottle of 30 with child resistant closure of 300 mg strength. HDPE bottles of 600 for both strengths. | Tentatively Approved | View Label | Lamivudine | Tablets | Hetero Labs Limited Unit III Plot No. 22-110, Part-II, Industrial Development Area Jeedimetla, Hyderabad, Telangana, India 500055. | No | Single | Yes | For Pediatric patients at least 3 months of age and weighing at least 14 kg. | Store lamivudine tablets at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). | 24 | Not Scored | Tentatively Approved 1/29/2008 | India | https://www.heteroworld.com/contact-us.php | 59 | Yes |
| 078864 | Approved | Nevirapine Tablets | 200 mg | Mylan Laboratories Limited | ANDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 05/22/2012 | HDPE bottle of 60.Blister packs of 10 unit doses in cartons of 60 (6X10). | Approved | View Label | Nevirapine | Tablets | Mylan Laboratories Limited (FDF-1) Plot No. F-4 and F-12 Malegaon M.I.D.C., Sinnar Nashik District, Maharashtra, India. 422113 Mylan Laboratories Limited (FDF-2) Plot No. H-12 & H-13 MIDC, Waluj. Aurangabad, Maharashtra, India. 431136 Mylan Laboratories Limited (FDF-3) Plot No. 11, 12 and 13, Indore Special Economic Zone Pharma Zone, Phase-II, Sector-III, Pithampur Dhar district, Madhya Pradesh, India. 454775. | No | Single | Yes | For Pediatric patients at least 15 days of age. | Store at 20 to 25°C (68° to 77°F). | 36 | Scored | Approved 05/22/2012 TA'd 5/15/2008 | India | https://www.mylan.com/en/contact-mylan | 69 | Yes |
| 078883 | Tentatively Approved | Efavirenz Tablets | 600 mg | Mylan Laboratories Limited | ANDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 07/12/2007 | HDPE bottles of 30 and 90. Blister packs of 30 unit doses. | Tentatively Approved | View Label | Efavirenz | Tablets | Mylan Laboratories Limited (FDF-1) Plot No. F/4 and F/12 Malegaon MIDC, Sinnar Nashik District, Maharashtra, India. 422113. Mylan Laboratories Limited (FDF-2) Plot No. H-12 & H-13 MIDC, Waluj, Aurangabad, Maharashtra, India. 431136. Mylan Laboratories Limited (FDF-3) Plot No. 11, 12 & 13, Indore Special Economic Zone Pharma Zone, Phase - II, Sector - III, Pithampur District Dhar, Madhya Pradesh, India. 454775. | No | Single | Yes | For Pediatric patients at least 3 years of age and weighing at least 10 kg. | Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). | Not Scored | Tentatively Approved 7/12/2007 | India | https://www.mylan.com/en/contact-mylan | 48 | No | |
| 078886 | Approved | Efavirenz Tablets | 600 mg | Hetero Labs Limited Unit III | ANDA | Hetero Labs Limited | Camber Pharmaceuticals, Inc. | 04/27/2018 | HDPE bottles of 30 and 250. | Approved | View Label | Efavirenz | Tablets | Hetero Labs Limited Unit III Plot No. 22-110, Part-II, IDA Jeedimetla, Hyderabad, Telangana, India 500055. Hetero Labs Limited Unit-V SEZ Unit I TSIIC SEZ,, Polepally Village, Jadcherla Mandal, Mahaboob Nagar, Telangana, India 509301 | No | Single | Yes | For Pediatric patients at least 3 months of age and weighing at least 3.5 kg. | Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). | Not Scored | Approved 4/27/2018 Tentatively Approved 2/29/2008 | India | https://www.heteroworld.com/contact-us.php | 63 | Yes | |
| 078887 | Tentatively Approved | Nevirapine Tablets | 200 mg | Emcure Pharmaceuticals Limited | ANDA | Emcure Pharmaceuticals Limited | Emcure Pharmaceuticals Limited | 09/28/2007 | HDPE bottle of 60. | Tentatively Approved | View Label | Nevirapine | Tablets | Emcure Pharmaceuticals Limited Plot No. P-2, I.T.B.T. Park, Phase-II, MIDC, Hinjawadi Pune, Maharashtra, India. 411057. | No | Single | Yes | For Pediatric patients at least 15 days of age. | Store at 20°C to 25°C (68 to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). | 36 | Scored | Tentatively Approved 9/28/2007 | India | https://emcure.com/contactus | 52 | No |
| 078922 | Approved | Zidovudine Tablets | 300 mg | Mylan Pharmaceuticals Inc. | ANDA | Mylan Laboratories Limited | Mylan Pharmaceuticals Inc. | 02/14/2008 | HDPE bottle of 60. | Approved | View Label | Zidovudine | Tablets | Mylan Laboratories Limited (FDF-1) Plot # F/4 and F/12 Malegaon M.I.D.C. Sinnar Nashik District, Maharashtra, India. 422113. | No | Single | Yes | For Pediatric patients at least 4 weeks of age, weighing at least 30 kg, and can reliable swallow whole tablets. | Store at 20 to 25°C (68 to 77°F). | 48 | Not Scored | Approved 2/14/2008 | India | https://www.mylan.com/en/contact-mylan | 61 | Yes |
| 078929 | Tentatively Approved | Lamivudine and Zidovudine Tablets | 150 mg/300 mg | Emcure Pharmaceuticals Limited | ANDA | Emcure Pharmaceuticals Limited | Emcure Pharmaceuticals Limited | 08/08/2007 | HDPE bottles of 60. Blister packs of 10 unit doses. | Tentatively Approved | View Label | Lamivudine and Zidovudine | Tablets | Emcure Pharmaceuticals Limited Plot No. P-2, I.T.B.T. Park, Phase-II, MIDC, Hinjawadi Pune, Maharashtra, India. 411057. | No | 2-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 30 kg. | Store at 20 to 25°C (68 to 77°F). | 36 | Not Scored | Tentatively Approved 8/08/2007 | India | https://emcure.com/contactus | 49 | No |
| 078957 | Withdrawn | Stavudine Capsules | 15 mg, 20 mg, 30 mg, 40 mg | Hetero Labs Limited Unit III | ANDA | Withdrawn | Stavudine | Capsules | No | Single | Yes | Not Scored | Withdrawn FR Effective 4/8/2020 Withdrawn 11/1/2019 Approved 12/29/2008 Tentatively Approved 2/28/2008 | https://www.heteroworld.com/contact-us.php | 62 | No | ||||||||||
| 078958 | Tentatively Approved | Efavirenz Tablets | 600 mg | Emcure Pharmaceuticals Limited | ANDA | Emcure Pharmaceuticals Limited | Heritage Pharmaceuticals Inc. | 12/20/2007 | HDPE bottles of 30 and 60. | Tentatively Approved | View Label | Efavirenz | Tablets | Emcure Pharmaceuticals Limited Plot No. P-2, I.T.B.T. Park, Phase-II, MIDC, Hinjawadi Pune, Maharashtra, India. 411057. | No | Single | Yes | For Pediatric patients at least 3 months of age and weighing at least 3.5 kg. | Efavirenz tablets should be stored at 20 to 25°C (68 to 77°F); excursions permitted between 15 to 30°C (59 to 86°F). | 36 | Not Scored | Tentatively Approved 12/20/2007 | India | https://emcure.com/contactus | 58 | No |
| 079071 | Approved | Tenofovir Disoproxil Fumarate Tablets | 300 mg | Mylan Laboratories Limited | ANDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 02/29/2024 | HDPE bottles of 30 and 100.Cartons of 20 unit dose tablets in blister packs of 10 (2X10). | Approved | View Label | Tenofovir Disoproxil Fumarate | Tablets | Mylan Laboratories Limited (FDF-1) Plot No. F/4 and F/12 Malegaon MIDC, Sinnar Nashik District, Maharashtra, India. 422113. Mylan Laboratories Limited (FDF-2) Plot No. H-12 & H-13 MIDC, Waluj, Aurangabad, Maharashtra, India. 431136. | No | Single | Yes | For Pediatric patients at least 2 years of age and weighing at least 10 kg. | Store at 20 to 25°C (68 to 77°F). | 36/24/24 | Not Scored | Fully Approved 2/29/2024; Tentatively Approved 11/30/2007 | India | https://www.mylan.com/en/contact-mylan | 56 | Yes |
| 079074 | Tentatively Approved | Lopinavir and Ritonavir Tablets | 200 mg/50 mg | Mylan Laboratories Limited | ANDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 03/10/2009 | HDPE bottles of 120.Blister packs of 12 unit doses (2X6). | Tentatively Approved | View Label | Lopinavir and Ritonavir | Tablets | Mylan Laboratories Limited (FDF-1) Plot No. F-4 and F-12 Malegaon M.I.D.C., Sinnar Nashik District, Maharashtra, India. 422113 Mylan Laboratories Limited (FDF-3) Plot No. 11, 12 and 13, Indore Special Economic Zone Pharma Zone, Phase-II, Sector-III, Pithampur Dhar district, Madhya Pradesh, India. 454775. | No | 2-Fixed Dose Combination | Yes | For Pediatric patients at least 6 months of age. | Store lopinavir and ritonavir film-coated tablets at 25°C (77°F); excursions permitted to 15-30°C(59 to 86°F) | 24 | Not Scored | Tentatively Approved 3/10/2009 | India | https://www.mylan.com/en/contact-mylan | 83 | Yes |
| 079079 | Approved | Lamivudine and Zidovudine Tablets | 150 mg/300 mg | Mylan Pharmaceuticals Inc. | ANDA | Mylan Laboratories Limited | Mylan Pharmaceuticals Inc. | 08/12/2019 | HDPE bottle of 60. Carton of 60 unit dose tablets (6X10). | Approved | View Label | Lamivudine and Zidovudine | Tablets | Mylan Laboratories Limited (FDF-1) Plot No. F/4 and F/12 Malegaon MIDC, Sinnar Nashik District, Maharashtra, India. 422113. Mylan Laboratories Limited (FDF-2) Plot No. H-12 & H-13 MIDC, Waluj, Aurangabad, Maharashtra, India. 431136. Mylan Laboratories Limited (FDF-3) Plot No. 11, 12 & 13, Indore Special Economic Zone Pharma Zone, Phase - II, Sector - III, Pithampur District Dhar, Madhya Pradesh, India. 454775. | No | 2-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 30 kg. | Store between 20 and 30°C (36 and 86°F). | 48 | Scored | Approved 8/12/2019 Tentatively Approved 11/29/2007 | India | https://www.mylan.com/en/contact-mylan | 55 | No |
| 079124 | Approved | Lamivudine and Zidovudine Tablets | 150 mg/300 mg | Hetero Labs Limited Unit III | ANDA | Hetero Labs Limited | Hetero Labs Limited | 09/17/2015 | HDPE bottles of 60 and 500. | Approved | View Label | Lamivudine and Zidovudine | Tablets | Hetero Labs Limited Unit III Plot No. 22-110, Part-II, IDA Jeedimetla, Hyderabad, Telangana, India. 500055 Hetero Labs Limited Unit - V Sy. No.: 439, 440, 441 & 458, TSIIC Formulation SEZ Polepally Village, Jadcherla Mandal Mahabubnagar, Telangana, India 509301 | No | 2-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 30 kg. | Store at 20 to 25°C (68 to 77°F). | 36 | Scored | Approved 09/17/2015 Tentatively Approved 4/25/200 | India | https://www.heteroworld.com/contact-us.php | 66 | Yes |
| 079128 | Approved | Lamivudine and Zidovudine Tablets | 150 mg/300 mg | Strides Pharma Global PTE Limited | ANDA | Strides Pharma Science Limited | Strides Pharma Inc. | 05/13/2015 | HDPE bottle of 60. | Approved | View Label | Lamivudine and Zidovudine | Tablets | Strides Pharma Science Limited No 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bengaluru, Karnataka, India. 562106. | No | 2-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 30 kg. | Store at 20 to 25°C (68 to 77°F). | 24 | Scored | Approved 5/13/2015 TA'd 10/18/2010 | India | http://www.strides.com/contact.aspx | 120 | Yes |
| 079188 | Approved | Emtricitabine Capsules | 200 mg | Aurobindo Pharma Limited | ANDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 03/15/2023 | HDPE bottles 30 and 500. | Approved | View Label | Emtricitabine | Capsules | Aurobindo Pharma Limited Unit-III, Survey 313 & 314, Bachupally, Bachupally, Mandal, Medchal-Malkajgiri District Medchal, Telangana 500 090 India | No | Single | Yes | For Pediatric patients at least 3 months of age and weighing at least 33 kg. | Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). | 24 | Not Scored | Approved 3/15/2023. Tentatively Approved 5/9/2008. | India | https://www.aurobindousa.com/contact/ | 68 | Yes |
| 090049 | Tentatively Approved | Emtricitabine and Tenofovir Disoproxil Fumarate Tablets | 200 mg/300 mg | Mylan Laboratories Limited | ANDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 03/30/2009 | HDPE bottles of 30 and 100.Blister packs of 10 unit doses in 20 unit dose cartons (2X10). | Tentatively Approved | View Label | Emtricitabine and Tenofovir Disoproxil Fumarate | Tablets | Mylan Laboratories Limited (FDF-1) Plot No. F-4 and F-12 Malegaon M.I.D.C., Sinnar Nashik District, Maharashtra, India. 422113 Mylan Laboratories Limited (FDF-2) Plot No. H-12 & H-13 MIDC, Waluj. Aurangabad, Maharashtra, India. 431136 Mylan Laboratories Limited (FDF-3) Plot No. 11, 12 and 13, Indore Special Economic Zone Pharma Zone, Phase-II, Sector-III, Pithampur Dhar district, Madhya Pradesh, India. 454775. | No | 2-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 17 kg and for whom a solid dosage form is appropriate. | Store at 20 to 25°C (68 to 77°F). | Not Scored | Tentatively Approved 3/30/2009 | India | https://www.mylan.com/en/contact-mylan | 87 | Yes | |
| 090092 | Approved | Zidovudine Tablets | 300 mg | Hetero Labs Limited Unit III | ANDA | Hetero Labs Limited Unit III and Ascent Pharmaceuticals | Camber Pharmaceuticals, Inc | 04/25/2008 | HDPE bottle of 60 and 600 tablets. | Approved | View Label | Zidovudine | Tablets | Hetero Labs Limited Unit III Plot No. 22-110, Part-II, IDA Jeedimetla, Hyderabad, Telangana, India. 500055 Ascent Pharmaceuticals, Inc. 400 S Technology Dr Central Islip, New York, USA. 11722 | No | Single | Yes | For Pediatric patients at least 4 weeks of age and weighing at least 4 kg. | Store at 20 to 25° C (68 to 77°F). | 36 | Not Scored | Approved 4/25/2008 | India | https://www.heteroworld.com/contact-us.php | 67 | Yes |
| 090094 | Approved | Didanosine Delayed-Release Capsules | 125 mg, 200 mg, 250 mg, 400 mg | Aurobindo Pharma Limited | ANDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 09/24/2008 | HDPE bottles of 30 and 500 of all dosage strengths. Blister packs of 14 unit doses in cartons of 140 (10 x 14) of the 125 mg strength. Blister packs of 10 unit doses in cartons of 100 (10X10) of the 200 mg and 250 mg strength. Blister packs of 5 unit do | Approved | View Label | Didanosine | Delayed - release Capsules | Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090 | No | Single | Yes | For Pediatric patients at least 6 years of age and weighing at least 20 kg. | Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). | 24 | Not Scored | Approved 9/24/2008 | India | https://www.aurobindousa.com/contact-us/ | 75 | No |
| 090155 | Tentatively Approved | Efavirenz Capsules | 200 mg | Cipla Limited | ANDA | Cipla Limited | Cipla Limited | 08/03/2009 | HDPE bottle of 90 with child-resistant cap, induction seal, and desiccantHDPE bottle of 1000 with screw cap and desiccant | Tentatively Approved | View Label | Efavirenz | Capsules | Cipla limited Goa (Unit VII) Plot no. L-147 - 147-1, Verna Industrial Estate, Verna Salcette, Goa, India. 403722 | No | Single | Yes | For Pediatric patients at least 3 months of age and weighing at least 7.5 kg. | Efavirenz capsules should be stored at 25°C (77° F); excursions permitted to 15–30° C(59–86° F). | 24 | Not Scored | Tentatively Approved 8/03/2009 | India | https://www.cipla.com/en/contact-us.html | 99 | Yes |
| 090159 | Approved | Abacavir and Lamivudine Tablets | 600 mg/300 mg | Aurobindo Pharma Limited | ANDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 11/15/2018 | HDPE bottle of 30 with child-resistant closure.Blister packs of ten unit doses in cartons of 100 (10X10). | Approved | View Label | Abacavir and Lamivudine | Tablets | Aurobindo Pharma Limited Unit-III, Survey 313 & 314, Bachupally, Bachupally, Mandal, Medchal-Malkajgiri District Medchal, Telangana 500 090 India | No | 2-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 25 kg. | Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). | 24 | Not Scored | Approved 11/15/2018 TA'd 9/03/2008 | India | https://www.aurobindousa.com/contact-us/ | 72 | Yes |
| 090198 | Approved | Lamivudine Tablets | 150 mg, 300 mg | Macleods Pharmaceuticals Limited | ANDA | Macleods Pharmaceuticals Limited | Macleods Pharma USA, Inc. | 05/01/2019 | HDPE bottle of 60 of the 150 mg tablets.HDPE bottle of 30 of the 300 mg tablets. | Approved | View Label | Lamivudine | Tablets | Macleods Pharmaceuticals Limited Survey No 366, Premier Industrial Estate, Kachigam Plot No. 25 - 27 Daman, Daman, India.396210. | No | Single | Yes | For Pediatric patients at least 3 months of age and weighing at least 14 kg. | Store lamivudine tablets at 20 to 25°C (68 to 77° F); excursions permitted to 15 to 30° C (59 to 86° F). | 36 | Not Scored | Approved 5/1/2019 Tentatively Approved 10/7/2008 | India | http://www.macleodspharma.com/UnitedStates.asp | 76 | Yes |
| 090309 | Tentatively Approved | Abacavir Sulfate, Lamivudine, and Zidovudine Tablets | 300 mg/150 mg/300 mg | Mylan Laboratories Limited | ANDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 07/15/2009 | HDPE bottle of 60. | Tentatively Approved | View Label | Abacavir Sulfate, Lamivudine, and Zidovudine | Tablets | Mylan Laboratories Limited (FDF-1) Plot No. F-4 and F-12 Malegaon M.I.D.C., Sinnar Nashik District, Maharashtra, India. 422113 | No | 3-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 40 kg. | Store at 20 to 25°C (68 to 77°F). | 24 | Not Scored | Tentatively Approved 7/15/2009 | India | https://www.mylan.com/en/contact-mylan | 95 | Yes |
| 090371 | Tentatively Approved | Lopinavir and Ritonavir Tablets | 200 mg/50 mg, 100 mg/25 mg | Cipla Limited | ANDA | Cipla Limited | Cipla Limited | 11/20/2019 | HDPE bottles of 120 of 200 mg/50 mg tablets.HDPE bottles of 60 of 100 mg/25 mg tablets. | Tentatively Approved | View Label | Lopinavir and Ritonavir | Tablets | Cipla limited, Patalganga Cipla Limited, A-42, MIDC, Dist: Raigad, Patalganga, Maharashtra, India. 410220 | No | 2-Fixed Dose Combination | Yes | For Pediatric patients at least 6 months of age and weighing at least 15 kg. | Store at 20°C to 25°C (68°F to 77°F);excursions permitted to 15°C to 30°C (59°F to 86°F). | 24 | Not Scored | Tentatively Approved 11/20/2009 | India | https://www.cipla.com/en/contact-us.html | 104 | Yes |
| 090433 | Withdrawn | Lamivudine Tablets | 150 mg | Alkem Laboratories Limited | ANDA | Withdrawn | Lamivudine | Tablets | No | Single | Yes | Not Scored | Withdrawn 2/24/2017 Tentatively Approved 3/16/2009 | https://www.alkemlabs.com/contact-us | 85 | No | ||||||||||
| 090437 | Tentatively Approved | Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate Tablets | 600 mg/200 mg/300 mg | Mylan Laboratories Limited | ANDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 08/12/2009 | HDPE bottles of 30 and 100. | Tentatively Approved | View Label | Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate | Tablets | Mylan Laboratories Limited (FDF-1) Plot No. F-4 and F-12 Malegaon M.I.D.C., Sinnar Nashik District, Maharashtra, India. 422113 Mylan Laboratories Limited (FDF-2) Plot No. H-12 & H-13 MIDC, Waluj. Aurangabad, Maharashtra, India. 431136 Mylan Laboratories Limited (FDF-3) Plot No. 11, 12 and 13, Indore Special Economic Zone Pharma Zone, Phase-II, Secot-III, Pithampur Dhar district, Madhya Pradesh, India. 454775. | No | 3-Fixed Dose Combination | No | Not recommended for use in patient under 18 years of age. | Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). | Not Scored | Tentatively Approved 8/12/2009 | India | https://www.mylan.com/en/contact-mylan | 101 | Yes | |
| 090457 | Approved | Lamivudine Tablets | 150 mg, 300 mg | Strides Pharma Global PTE Limited | ANDA | Strides Pharma Science Limited | Strides Pharma Inc. | 04/19/2018 | HDPE bottles of 60 of the 150 mg tablets.HDPE bottles of 30 of the 300 mg tablets. | Approved | View Label | Lamivudine | Tablets | Strides Pharma Science Limited No 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bengaluru, Karnataka, India. 562106 | No | Single | Yes | For Pediatric patients at least 3 months of age and weighing at least 14 kg. | Store lamivudine tablets at 20 to 25°C (68 to 77°F). | 24 | Not Scored | Approved 4/19/2018 Tentatively Approved 8/06/2009 | India | http://www.strides.com/contact.aspx | 100 | Yes |
| 090471 | Tentatively Approved | Lopinavir and Ritonavir Tablets | 100 mg/25 mg, 200 mg/50 mg | Aurobindo Pharma Limited | ANDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 03/10/2009 | HDPE bottle of 120 for 200 mg/50 mg strength.HDPE bottle of 60 for 100 mg/25 mg strength. | Tentatively Approved | View Label | Lopinavir and Ritonavir | Tablets | Aurobindo Pharma Limited Unit-III, Sy. No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District, Medchal, Telangana, India. 500090. | No | 2-Fixed Dose Combination | Yes | For pediatric patients at least 6 months of age. | Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). | 36 | Not Scored | Tentatively Approved 3/10/09 | India | https://www.aurobindousa.com/contact-us/ | 84 | Yes |
| 090488 | Tentatively Approved | Emtricitabine Capsules | 200 mg | Mylan Laboratories Limited | ANDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 12/23/2008 | HDPE bottles of 30 and 100. Blister packs of 20 unit doses (2X10) and 30 unit doses (3X10) | Tentatively Approved | View Label | Emtricitabine | Capsules | Mylan Laboratories Limited (FDF-1) Plot No. F-4 and F-12 Malegaon M.I.D.C., Sinnar Nashik District, Maharashtra, India. 422113 | No | Single | Yes | For Pediatric patients at least 3 months of age, weighing at least 33 kg, and for whom as solid dosage form is appropriate. | Store at 25°C (77°F); excursions permitted to 15°C to 30°C ( 59°F to 86°F). | 24 | Not Scored | Tentatively Approved 12/23/2008 | India | https://www.mylan.com/en/contact-mylan | 80 | No |
| 090513 | Approved | Emtricitabine and Tenofovir Disoproxil Fumarate Tablets | 200 mg/300 mg | Aurobindo Pharma Limited | ANDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 01/26/2018 | HDPE bottle of 30 with child-resistant closure and desiccant | Approved | View Label | Emtricitabine and Tenofovir Disoproxil Fumarate | Tablets | Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090 Aurobindo Pharma Limited Unit-VII, Sy.No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No.S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India. 509302. | No | 2-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 17 kg. | Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). | 24 | Not Scored | Approved 1/26/2018 Tentatively Approved 3/30/2009 | India | https://www.aurobindousa.com/contact-us/ | 89 | Yes |
| 090519 | Tentatively Approved | Abacavir Sulfate and Lamivudine Tablets | 600 mg/300 mg | Mylan Laboratories Limited | ANDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 03/30/2009 | HDPE bottle of 30. | Tentatively Approved | View Label | Abacavir Sulfate and Lamivudine | Tablets | Mylan Laboratories Limited (FDF-1) Plot No. F/4 and F/12 Malegaon MIDC, Sinnar Nashik Dist., Maharashtra, 422-113 India Mylan Laboratories Limited (FDF-3) Plot No. 11, 12 and 13, Indore Special Economic Zone Pharma Zone, Phase-II, Sector-III, Pithampur Dhar district, Madhya Pradesh, India. 454775. | No | 2-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 25 kg. | Do not store above 30°C. Store in original container. | 24 | Not Scored | Tentatively Approved 3/30/2009 | India | https://www.mylan.com/en/contact-mylan | 88 | Yes |
| 090561 | Approved | Zidovudine Tablets | 300 mg | Cipla Limited | ANDA | Cipla Limited | Cipla Limited | 10/27/2010 | HDPE Bottles of 60 and 1000.Unit dose boxes of 100 tablets. | Approved | View Label | Zidovudine | Tablets | Cipla Limited, Unit -VII Plot No. S-103 to S- 105, S-107 to S-112 & L-147, L-147/1 to L-147/3, L-147/A & L-138 Verna Industrial Estate, Verna, Salcette, Goa – 403 722, India | No | Single | Yes | For Pediatric patients at least 4 weeks of age. | Store at 20 to 25°C (68 to 77°F). | 24 | Not Scored | Approved 10/27/2010 | India | https://www.cipla.com/en/contact-us.html | 121 | Yes |
| 090636 | Approved | Tenofovir Disoproxil Fumarate Tablets | 300 mg | Hetero Labs Limited Unit III | ANDA | Hetero Labs Limited Unit III | Camber Pharmaceuticals, Inc | 01/26/2018 | HDPE bottles of 30, 60, 100, 500, and 1000. | Approved | View Label | Tenofovir Disoproxil Fumarate | Tablets | Hetero Labs Limited Unit-III Plot No. 22-110, Industrial Development Area Jeedimetla, Hyderabad, Telanagana, India. 500055 | No | Single | Yes | For Pediatric patients at least 2 years of age and weighing at least 17 kg. | Store at 20 to 25°C (68 to 77°F). | 24 | Not Scored | Approved 1/26/2018 Tentatively Approved 4/2/2010 | India | https://www.heteroworld.com/contact-us.php | 109 | Yes |
| 090647 | Approved | Tenofovir Disoproxil Fumarate Tablets | 150 mg, 200 mg, 250 mg, 300 mg | Aurobindo Pharma Limited | ANDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 01/26/2018 | HDPE bottles of 30 of 150mg, 200mg, 250 mg, and 300 mg. Blister packs of 10 unit dose tablets in cartons of 3 (3X10) for 150 g, 200 mg, and 250 mg. | Approved | View Label | Tenofovir Disoproxil Fumarate | Tablets | Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090 Aurobindo Pharma Limited Unit-VII, Sy.No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No.S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India. 509302. | No | Single | Yes | For Pediatric patients at least 2 years of age and weighing at least 17 kg. | Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). | 24 | Not Scored | Approved 1/26/2018 Tentatively Approved 2/18/2009 | India | https://www.aurobindousa.com/contact-us/ | 81 | Yes |
| 090679 | Approved | Lamivudine and Zidovudine Tablets | 150 mg/300 mg | Macleods Pharmaceuticals Limited | ANDA | Macleods Pharmaceuticals Limited | Macleods Pharma USA, Inc. | 08/29/2018 | HDPE bottles of 60. Blister packs of 10 unit doses packed in 60's (6X10) and 120's (12X10). | Approved | View Label | Lamivudine and Zidovudine | Tablets | Macleods Pharmaceuticals Limited Plot No. 25 – 27, Survey No. 366, Premier Industrial Estate, Kachigam, Daman – 396210, India. | No | 2-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 30 kg. | Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). | Scored | Approved 8/29/2018 Tentatively Approved 5/29/2009 | India | http://www.macleodspharma.com/UnitedStates.asp | 93 | Yes | |
| 090688 | Approved | Nevirapine Tablets | 200 mg | Macleods Pharmaceuticals Limited | ANDA | Macleods Pharmaceuticals Limited | Macleods Pharma USA, Inc. | 01/14/2019 | HDPE bottle of 60.Blister packs of ten unit doses in cartons of 60 (6x10)Blister packs of ten unit doses in cartons of 120 (12x10) | Approved | View Label | Nevirapine | Tablets | Macleods Pharmaceuticals Limited Plot No 25-27, Survey No. 366 Premier Industrial Estate, Kachigam Daman,Daman, India. 396210. | No | Single | Yes | For Pediatric patients at least 15 days of age. | Store between 20 to 25°C (77°F); excursions permitted to 15– 30°C (59–86°F). | 24 | Scored | Approved 1/14/2019 TA'd 3/31/2009 | India | http://www.macleodspharma.com/UnitedStates.asp | 90 | Yes |
| 090742 | Approved | Tenofovir Disoproxil Fumarate Tablets | 300 mg | Strides Pharma Global Pte. Ltd. | ANDA | Strides Pharma Science Limited | Strides Pharma Inc. | 01/26/2018 | HDPE bottles of 30 with child-resistant cap and desiccant. | Approved | View Label | Tenofovir Disoproxil Fumarate | Tablets | Strides Pharma Science Limited No 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bengaluru, Karnataka, India. 562106 | No | Single | Yes | For Pediatric patients at least 2 years of age. | Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). | 24 | Not Scored | Approved 1/26/2018 Tentatively Approved 5/25/2011 | India | http://www.strides.com/contact.aspx | 131 | Yes |
| 090788 | Approved | Didanosine Delayed-Release Capsules | 125 mg, 200 mg, 250 mg, 400 mg | Mylan Pharmaceuticals Inc. | ANDA | Mylan Laboratories Limited | Mylan Pharmaceuticals Inc. | 04/08/2010 | HDPE bottles of 30 and 500. | Approved | View Label | Didanosine | Delayed - Release Capsules | Mylan Laboratories Limited (FDF-1) Plot No. F-4 and F-12 Malegaon M.I.D.C., Sinnar Nashik District, Maharashtra, India. 422113 | No | Single | Yes | For Pediatric patients at least 6 years of age and weighing at least 20 kg. | Store at 20 to 25°C (68 to 77°F). Protect from moisture. | 24 | Not Scored | Approved 4/8/2010 | India | https://www.mylan.com/en/contact-mylan | 110 | No |
| 090958 | Approved | Emtricitabine and Tenofovir Disoproxil Fumarate Tablets | 200 mg/300 mg | Cipla Limited | ANDA | Cipla Limited | Cipla USA, Inc. | 04/02/2021 | HDPE bottles of 30 with child-resistant closure and desiccant. | Approved | View Label | Emtricitabine and Tenofovir Disoproxil Fumarate | Tablets | Cipla Limited Unit-II, Plot No.-A-42, MIDC, Patalganga, District Raigad Maharashtra. Pin code: 410 220, India | No | 2-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 35 kg. | Store at 20 to 25°C (68 to 77 °F). | 24 | Not Scored | TA'd 2/26/2014 Approved 04/02/2021 | India | https://www.cipla.com/en/contact-us.html | 168 | Yes |
| 091050 | Approved | Abacavir Sulfate Tablets | 300 mg | Strides Pharma Global PTE Limited | ANDA | Strides Pharma Science Limited | Strides Pharma, Inc. | 10/28/2016 | HDPE bottle of 60. Unit dose blister packs of 60 tablets. Each pack contains 6 blister cards of 10 tablets each. | Approved | View Label | Abacavir Sulfate | Tablets | Strides Pharma Science Limited No 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bengaluru, Karnataka, India. 562106 | No | Single | Yes | For Pediatric patients weighing at least 14 kg. | Store at controlled room temperature of 20 to 25°C (68 to 77°F). | 24 | Scored | Approved 10/28/2016 Tentatively Approved 5/12/2010 | India | http://www.strides.com/contact.aspx | 111 | No |
| 091055 | Approved | Emtricitabine and Tenofovir Disoproxil Fumarate Tablets | 200 mg/300 mg | Strides Pharma Global PTE Ltd | ANDA | Strides Pharma Science Limited | Strides Pharma Global PTE Ltd | 01/13/2021 | HDPE bottles of 30 with desiccant and child-resistant closure. | Approved | View Label | Emtricitabine and Tenofovir Disoproxil Fumarate | Tablets | Strides Pharma Science Limited No 36/7, Suragajakkanahalli, Indlavadi Cross, Anekal Taluk. Bengaluru, Karnataka, India 562106 | No | 2-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 17 kg. | Store at 20 to 25°C (68 to 77°F)) [see USP Controlled Room Temperature]. Protect from light. | 24 | Not Scored | Approved 01/13/2021, TA'd 7/31/2013 | India | http://www.strides.com/contact.aspx | 162 | Yes |
| 091144 | Approved | Abacavir and Lamivudine Tablets | 600 mg/300 mg | Cipla Limited | ANDA | Cipla Limited | Cipla USA, Inc. | 03/28/2017 | HDPE bottles 30. Unit dose bottles of 30 tablets (3X10). | Approved | View Label | Abacavir Sulfate and Lamivudine | Tablets | Cipla limited, Patalganga Cipla Limited, Unit 1, A-33, MIDC, Dist: Raigad, Patalganga, Maharashtra, India. 410220 Cipla Limited, Goa Unit VII Plot No. S- 103 to S- 105, S-107 to S-112 & L-147, L-147/1 to L- 147/3, L-147/A & L-138 Verna Industrial Estate, Verna, Salcette Verna. Goa, India. 403722. | No | 2-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 25 kg. | Store at 25°C (77°F); excursions permitted to 15 to 30°C (59° to 86°F). | 24 | Not Scored | Approved 3/28/2017 Tentatively Approved 1/31/2012 | India | https://www.cipla.com/en/contact-us.html | 140 | Yes |
| 091168 | Approved | Emtricitabine Capsules | 200 mg | Cipla Limited | ANDA | Cipla Limited | Cipla USA, Inc. | 07/02/2018 | HDPE bottles of 30 and 1000. | Approved | View Label | Emtricitabine | Capsules | Cipla Limited, Unit VII, Unit-VII, Plot No.: L147 to L-147/1 Verna Industrial Estate Verna, Salcette, Goa India 403722 | No | Single | Yes | For Pediatric patients at least 3 months of age and weighing at least 33 kg. | Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F - 86°F). | 24 | Not Scored | Approved 7/2/2018 Tentatively Approved 3/29/2011 | India | https://www.cipla.com/en/contact-us.html | 129 | Yes |
| 091203 | Withdrawn | Lopinavir and Ritonavir Oral Solution | 80 mg/20 mg per mL | Cipla Limited | ANDA | Withdrawn | Lopinavir and Ritonavir | Oral Solution | No | 2-Fixed Dose Combination | Yes | Not Scored | Withdrawn 2/25/2016 Tentatively Approved 6/29/2012 | https://www.cipla.com/en/contact-us.html | 153 | No | ||||||||||
| 091475 | Approved | Lamivudine Oral Solution | 10 mg/ml | Hetero Labs Limited Unit-III | ANDA | Hetero Labs Limited Unit-III | Hetero Labs Limited Unit III (formerly Hetero Drugs Limited) | 10/06/2023 | HDPE bottles of 240 mL with Expanded PE Wad.HDPE bottles of 240 mL with Induction Sealing FSE Wad. | Approved | View Label | Lamivudine | Oral Solution | Hetero Labs Limited Unit-III Plot No. 22-110, Part-II, IDA, Jeedimetla, Hyderabad, Telangana, India. 500055 | No | Single | Yes | For Pediatric patients at least 3 months of age. | Store in tightly closed bottles at 20 to 25°C (68 to 77°F). | 24 | Not Scored | Approved 10/6/2023 Tentatively Approved 5/29/2012 | India | https://www.heteroworld.com/contact-us.php | 148 | Yes |
| 091560 | Approved | Abacavir Sulfate Tablets | 300 mg | Hetero Labs Limited Unit III | ANDA | Hetero Labs Limited Unit III | Camber Pharmaceuticals, Inc | 09/13/2013 | HDPE bottle of 60. | Approved | View Label | Abacavir Sulfate | Tablets | HETERO LABS LIMITED UNIT III Plot No.22-110, Part-II, IDA Jeedimetla, Hyderabad, Telangana, India. 500055 | No | Single | Yes | For Pediatric patients at least 3 months of age. | Store below 30°C (86°F). | 24 | Scored | Approved 09/13/2013 TA'd 9/29/2010 | India | https://www.heteroworld.com/contact-us.php | 119 | Yes |
| 091579 | Tentatively Approved | Efavirenz Tablets | 600 mg | Macleods Pharmaceuticals Limited | ANDA | Macleods Pharmaceuticals Limited | Macleods Pharma USA, Inc. | 08/29/2011 | HDPE bottles of 30. | Tentatively Approved | View Label | Efavirenz | Tablets | Macleods Pharmaceuticals Limited Block N2, Village -Theda, Post Office - Lodhimajra, Tehsil - Baddi. Tehsil Baddi, District Solan, Himchal Pradesh, India 174101. | No | Single | Yes | For Pediatric patients at least 3 months of age and weighing at least 3.5 kg. | Store at 20 to 25°C (68 to 77°F); excursions permitted from 15 to 30°C(59° to 86°F). | 24 | Not Scored | Tentatively Approved 8/29/2011 | India | http://www.macleodspharma.com/UnitedStates.asp | 132 | Yes |
| 091593 | Tentatively Approved | Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate Tablets | 600 mg/200 mg/300 mg | Cipla Limited | ANDA | Cipla Limited | Cipla Limited | 02/27/2012 | HDPE bottles of 30 with three silica gel desiccant and a non child-resistant closure. | Tentatively Approved | View Label | Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate | Tablets | Cipla limited, Plot no. L-147 to L-147-1 (Unit VII) Verna Industrial Estate Verna, Salcette, Goa, India. 403722. | No | 3-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 40 kg. | Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). | 36 | Not Scored | Tentatively Approved 2/27/2012 | India | https://www.cipla.com/en/contact-us.html | 143 | Yes |
| 091611 | Tentatively Approved | Atazanavir Sulfate Capsules | 150 mg, 300 mg | Mylan Laboratories Limited | ANDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 09/15/2010 | HDPE bottles of 30. with child-resistant closure. | Tentatively Approved | View Label | Atazanavir Sulfate | Capsules | Mylan Laboratories Limited (FDF-1) Plot No. F-4 and F-12 Malegaon M.I.D.C., Sinnar Nashik District, Maharashtra, India. 422113 Mylan Laboratories Limited- (FDF-2) Plot No. H-12 & H-13 MIDC, Waluj, Aurangabad, Maharashtra, India. 431136 | No | Single | Yes | For Pediatric patients at least 6 years of age. | Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). | 24 | Not Scored | Tentatively Approved 9/15/2010 | India | https://www.mylan.com/en/contact-mylan | 118 | Yes |
| 091641 | Withdrawn | Atazanavir Capsules | 150 mg, 200 mg | Pharmacare Ltd | ANDA | Withdrawn | Atazanavir | Capsules | No | Single | Yes | Not Scored | Withdrawn 11/20/2018 Tentatively Approved 1/9/2017 | http://www.pharmacarelimited.com/contactus | 188 | No | ||||||||||
| 091677 | Approved | Lopinavir and Ritonavir Tablets | 200 mg/50 mg | Hetero Labs Limited Unit-III | ANDA | Hetero Labs Limited Unit-III | Hetero Labs Limited Unit-III | 06/04/2021 | HDPE Bottles 60 and 120 with child resistant closure. Blister pack of 80 (8x10) Unit dose tablets (Alu-Alu) & Blister pack of 80 (8x10) Unit dose tablets (Alu-PVC/PVdC) | Approved | View Label | Lopinavir and Ritonavir | Tablets | Hetero Labs Limited Unit-III Plot No. 22 -110, Part-II, Industrial Development Area, Jeedimetla, Hyderabad, Telangana, India. 500055 | No | 2-Fixed Dose Combination | Yes | For Pediatric patients at least 14 days or older. | Store at 20 to 25°C (86 to 77°F). | 24 | Not Scored | Approved 6/04/2021 Tentatively Approved 5/23/2012 | India | https://www.heteroworld.com/contact-us.php | 147 | No |
| 200196 | Tentatively Approved | Atazanavir Sulfate Capsules | 300 mg | Emcure Pharmaceuticals Limited | ANDA | Emcure Pharmaceuticals Limited | Emcure Pharmaceuticals Limited | 08/19/2010 | HDPE bottle of 30. | Tentatively Approved | View Label | Atazanavir Sulfate | Capsules | Emcure Pharmaceuticals Limited Plot No. P-2, I.T.B.T. Park, Phase-II, MIDC, Hinjawadi Pune, Maharashtra, India. 411057. | No | Single | Yes | For Pediatric patients at least 6 years of age and weighing at least 35 kg. | Store atazanavir capsules at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F). | 36 | Not Scored | Tentatively Approved 8/19/2010 | India | https://emcure.com/contactus | 115 | Yes |
| 200244 | Withdrawn | Lamivudine, Nevirapine, and Stavudine Tablets | 150 mg/200 mg/30 mg | Hetero Labs Limited Unit III | NDA | Withdrawn | Lamivudine, Nevirapine, and Stavudine | Tablets | No | 3-Fixed Dose Combination | Yes | Not Scored | Withdrawn 11/3/2017 Tentatively Approved 9/10/2010 | https://www.heteroworld.com/contact-us.php | 117 | No | ||||||||||
| 200406 | Tentatively Approved | Lamivudine Tablets | 150 mg, 300 mg | Micro Labs Limited India | ANDA | Micro Labs Limited | Micro Labs USA Inc. | 05/30/2012 | HDPE bottle of 30, 60, and 90. Blister Pack of 10 and cartons of 5 blister packs (5 X 10). | Tentatively Approved | View Label | Lamivudine | Tablets | Micro Labs Limited Plot No: S-155 to S-159 & N1, Phase III & Phase IV Verna Industrial Estate, Verna, Goa, India. 403722. | No | Single | Yes | For Pediatric patients at least 3 months of age and weighing at least 14 kg. | Store in tightly closed bottles at 25°C (77°F). | Not Scored | Tentatively Approved 5/30/2012 | India | http://www.microlabsusa.com/contactus | 149 | Yes | |
| 200623 | Tentatively Approved | Lamivudine and Tenofovir Disoproxil Fumarate Tablets | 300 mg/300 mg | Cipla Limited | NDA | Cipla Limited | Cipla Limited | 03/04/2011 | HDPE bottles of 30 and 500 with desiccant, heat-seal, and non child-resistant closure. | Tentatively Approved | View Label | Lamivudine and Tenofovir Disoproxil Fumarate | Tablets | Cipla limited, D-7, MIDC Industrial Area, Kurkumbh; Pune, Maharashtra, India. 413802 | No | 2-Fixed Dose Combination | Yes | For Pediatric patients at least 12 years of age and weighing at least 35 kg. | Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). | 24 | Not Scored | Tentatively Approved 3/04/2011 | India | https://www.cipla.com/en/contact-us.html | 127 | Yes |
| 200732 | Approved | Zidovudine Tablets | 100 mg | Mylan Laboratories Limited | NDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 02/23/2011 | HDPE bottles of 60 with induction seal and screw cap. | Approved | View Label | Zidovudine | Tablets | Mylan Laboratories Limited Plot No. F/4, F/12, Malegaon M.I.D.C. Sinnar, Nashik District - 422113, Maharashtra, India | No | Single | Yes | For Pediatric patients at least 4 weeks of age and weighing at least 5 kg. | Store at 20 to 25°C (68 to 77°F). Excursions permitted between 15 and 30°C (59 and 86°F). | 24 | Scored | Approved 2/23/2011 | India | https://www.mylan.com/en/contact-mylan | 126 | No |
| 200733 | Tentatively Approved | Abacavir Sulfate Tablets | 60 mg | Mylan Laboratories Limited | NDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 11/29/2010 | HDPE bottles of 60 with screw cap. | Tentatively Approved | View Label | Abacavir Sulfate | Tablets | Mylan Laboratories Limited (FDF-1) Plot No. F-4 and F-12 Malegaon M.I.D.C., Sinnar Nashik District, Maharashtra, India. 422113 Mylan Laboratories Limited (FDF-3) Plot No. 11, 12 &13, Indore Special Economic Zone Pharma Zone, Phase-II, Sector-III, Pithampur Dhar District, Madhya Pradesh, India. 454775. | No | Single | Yes | For Pediatric patients at least 3 months of age. | Store at 25°C (77°F); excursions permitted to 15 to 30°C (59°to 86°F). | 24 | Scored | Tentatively Approved 11/29/2010 | India | https://www.mylan.com/en/contact-mylan | 122 | No |
| 200748 | Tentatively Approved | Lamivudine and Zidovudine Tablets | 30 mg/60 mg | Mylan Laboratories Limited | NDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 01/05/2011 | HDPE bottle of 60 with screw cap. | Tentatively Approved | View Label | Lamivudine and Zidovudine | Tablets | Mylan Laboratories Limited (FDF-1) Plot No. F-4 and F-12 Malegaon M.I.D.C., Sinnar Nashik District, Maharashtra, India. 422113 | No | 2-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 5 kg. | Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). | 36 | Scored | Tentatively Approved 1/05/2011 | India | https://www.mylan.com/en/contact-mylan | 123 | No |
| 200793 | Tentatively Approved | Lamivudine, Nevirapine, and Zidovudine Tablets for Oral Suspension | 30 mg/50 mg/60 mg | Mylan Laboratories Limited | NDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 07/08/2010 | HDPE bottle of 60 with desiccant and screw cap. | Tentatively Approved | View Label | Lamivudine, Nevirapine, and Zidovudine | Tablet for Oral Suspension | Mylan Laboratories Limited (FDF-1) Plot No. F-4 and F-12 Malegaon M.I.D.C., Sinnar Nashik District, Maharashtra, India. 422113 Mylan Laboratories Limited- (FDF-2) Plot No. H-12 & H-13 MIDC, Waluj, Aurangabad, Maharashtra, India. 431136 Mylan Laboratories Limited (FDF-3) Plot No. 11, 12 and 13, Indore Special Economic Zone Pharma Zone, Phase-II, Sector -III, Pithampur Dhar District, Madhya Pradesh, India. 454775 | No | 3-Fixed Dose Combination | Yes | For Pediatric patients at least 3 months of age and weighing at least 5 kg. | Store in tightly closed bottles at 25°C (77°F) excursions permitted to 15 to 30°C (59 to 86°F). | 36 | Scored | Tentatively Approved 7/08/2010 | India | https://www.mylan.com/en/contact-mylan | 113 | Yes |
| 201107 | Approved | Abacavir Oral Solution | 20 mg/mL | Hetero Labs Ltd Unit III | ANDA | Hetero Labs Ltd Unit III | Camber Pharmaceuticals, Inc. | 09/26/2016 | HDPE bottles 240 mL with Expanded PE Wad.HDPE bottles 240 mL with Induction Sealing FSE Wad. | Approved | View Label | Abacavir | Oral Solution | Hetero Drugs Limited Unit III Plot No. 22-110, Part-II, IDA Jeedimetla, Hyderabad, Telangana India. -500 055. | No | Single | Yes | For Pediatric patients at least 3 months of age. | Store at 20 - 25°C (68 - 77°F). DO NOT FREEZE. May be refrigerated. | 24 | Not Scored | Approved 9/26/2016 Tentatively Approved 7/2/2012 | India | https://www.heteroworld.com/contact-us.php | 154 | Yes |
| 201151 | Withdrawn | Lamivudine and Zidovudine Tablets | 30 mg/60 mg | Cipla Limited | NDA | Withdrawn | Lamivudine and Zidovudine | Tablets | No | 2-Fixed Dose Combination | Yes | Not Scored | Withdrawn 11/12/2019 Tentatively Approved 9/22/2011 | https://www.cipla.com/en/contact-us.html | 134 | No | ||||||||||
| 201806 | Approved | Emtricitabine and Tenofovir Disoproxil Fumarate Tablets | 200 mg/300 mg | Hetero Labs Limited Unit III | ANDA | Hetero Labs Limited Unit III | Hetero Labs Limited Unit III | 10/07/2021 | HDPE bottles of 30 with child-resistant closure and desiccant. | Approved | View Label | Emtricitabine and Tenofovir Disoproxil Fumarate | Tablets | Hetero Labs Limited Unit III Plot No. 22-110, Part-II, IDA Jeedimetla, Hyderabad, Telangana, India. 500055 | No | 2-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 17 kg. | Store at 20 to 25°C (68 to 77°F). | 24 | Not Scored | Approved 10/7/2021 Tentatively Approved12/22/2011 | India | https://www.heteroworld.com/contact-us.php | 138 | Yes |
| 202007 | Tentatively Approved | Abacavir Sulfate and Lamivudine Tablets for Oral Suspension | 60 mg/30 mg | Cipla Limited | NDA | Cipla Limited | Cipla Limited | 05/12/2011 | HDPE bottles of 60 and 120 with desiccant and non child-resistant caps. Blister pack cartons of 60 (6X10). | Tentatively Approved | View Label | Abacavir Sulfate and Lamivudine | Tablets for Oral Suspension | Cipla Limited, A-33/A-42, A-2 MIDC, Patalganga Industrial Area, District: Raigad, Patalganga, Maharashtra, India. 410220 | No | 2-Fixed Dose Combination | Yes | For Pediatric patients at least 3 months of age. | Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). | 24 | Scored | Tentatively Approved 5/12/2011 | India | https://www.cipla.com/en/contact-us.html | 130 | Yes |
| 202042 | Approved | Efavirenz Capsules | 50 mg, 200 mg | Micro Labs Limited India | ANDA | Micro Labs Limited | Micro Labs Limited | 01/19/2012 | HDPE bottles of 30, 60, and 90 with child resistant cap and induction seal. | Approved | View Label | Efavirenz | Capsules | Micro Labs Limited Plot No: S-155 to S-159 & N1, Phase III & Phase IV Verna Industrial Estate, Verna, Goa, India. 403722. | No | Single | Yes | For Pediatric patients at least 3 years of age and weighing at least 10 kg. | Store at 25°C (77°F); excursions permitted to 15 - 30° C (59°-86°F) | Not Scored | Tentatively Approved 1/19/2012 | India | http://www.microlabsusa.com/contactus | 139 | Yes | |
| 202058 | Approved | Zidovudine Tablets | 300 mg | HEC Pharma USA Inc | ANDA | Sunshine Lake Pharma Co., Ltd. | Lannett Company, Inc. | 10/07/2011 | HDPE bottles of 60. | Approved | View Label | Zidovudine | Tablets | Sunshine Lake Pharma Co., Ltd. No. 1, Northern Industry Road, Northern Industry Park of Song Shan Lake Dongguan, Guangdong, China. 523808 | No | Single | Yes | For Pediatric patients at least 4 weeks of age. | Store at 20 to 25°C (68 to 77°F). | 36 | Not Scored | Approved 10/07/2011 | China | http://pharm.hec.cn/en/contact.aspx?AboutCateId=60 | 135 | No |
| 202157 | Tentatively Approved | Lamivudine, Nevirapine, and Zidovudine Tablets | 150 mg/200 mg/300 mg | Hetero Labs Limited Unit III | NDA | Hetero Labs Limited | Hetero Labs Limited Unit III | 11/18/2011 | HDPE bottles of 60, 100, and 500.Blister pack cartons of 80 (8 x10) both PVC and PVC/PVdC. | Tentatively Approved | View Label | Lamivudine, Nevirapine, and Zidovudine | Tablets | Hetero Labs Limited Unit III Plot No. 22-110, Part-II, IDA Jeedimetla, Hyderabad, Telangana, India. 500055 Hetero Labs Limited Unit - V Sy. No.: 439, 440, 441 & 458, TSIIC Formulation SEZ Polepally Village, Jadcherla Mandal Mahabubnagar, Telangana, India. 509301. | No | 3-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 30 kg. | Store below 30°C. | 36 | Not Scored | Tentatively Approved 11/18/2011 | India | https://www.heteroworld.com/contact-us.php | 137 | Yes |
| 202171 | Withdrawn | Lamivudine and Tenofovir Disoproxil Fumarate Tablets Co-packaged with Nevirapine Tablets | 300 mg/300 mg + 200 mg | Mylan Laboratories Limited | NDA | Withdrawn | Lamivudine/Tenofovir Disoproxil Fumarate + Nevirapine | Tablets | No | 4-Fixed Dose Combination | No | Not Scored | Withdrawn 04/6/2017 Tentatively Approved 9/8/2011 | https://www.mylan.com/en/contact-mylan | 133 | No | ||||||||||
| 202212 | Tentatively Approved | Nevirapine Tablets for Oral Suspension | 50 mg, 100 mg | Cipla Limited | NDA | Cipla Limited | Cipla Limited | 04/30/2012 | HDPE bottles of 60 with filler, desiccant (silica gel), and Child Resistant capsor Non-Child Resistant caps.HDPE bottles of 1000-tablet HDPE containers with filler, desiccant (silica gel), and Non-Child Resistantcaps. Blister pack cartons of 60 with 6 | Tentatively Approved | View Label | Nevirapine | Tablets for Oral Suspension | Cipla Limited, Patalganga unit II, A-42, A-2 MIDC, Patalganga Industrial Area, District: Raigad Patalganga, Maharashtra, India. 410220. | No | Single | Yes | For pediatric patients at least 15 days of age or older. | Store at 25°C (77°F); excursions permitted 15°C to 30°C (59°F to 86°F). | 24 | Scored | Tentatively Approved 4/30/2012 | India | https://www.cipla.com/en/contact-us.html | 144 | Yes |
| 202301 | Tentatively Approved | Efavirenz Tablets | 600 mg | Micro Labs Ltd India | ANDA | Micro Labs Limited | Micro Labs USA Inc. | 06/20/2012 | HDPE bottles of 30, 60, and 90; with induction seal and child-resistant cap. Blister Pack of 10 and cartons of 5 blister packs (5 X 10). | Tentatively Approved | View Label | Efavirenz | Tablets | Micro Labs Limited Plot No. S-155 to S-159 & N1, Verna Industrial Estate, Phase III & Phase IV Verna, Goa, India 403722 | No | Single | Yes | For Pediatric patients at least 3 months of age and weighing at least 3.5 kg. | Efavirenz tablets USP should be stored at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). | 36 | Not Scored | Tentatively Approved 6/20/2012 | India | http://www.microlabsusa.com/contactus | 151 | Yes |
| 202381 | Tentatively Approved | Abacavir and Lamivudine Tablets | 60 mg/30 mg | Mylan Laboratories Limited | NDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 01/31/2012 | HDPE bottles of 30 with child-resistant closure, induction seals, and desiccant. | Tentatively Approved | View Label | Abacavir Sulfate and Lamivudine | Tablets | Mylan Laboratories Limited (FDF-1) Plot No. F-4 and F-12, Malegaon M.I.D.C., Sinnar Nashik District, Maharashtra, India. 422113 | No | 2-Fixed Dose Combination | Yes | For Pediatric patients at least 3 months of age or older. | Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). | 24 | Scored | Tentatively Approved 1/31/2012 | India | https://www.mylan.com/en/contact-mylan | 141 | Yes |
| 202529 | Withdrawn | Lamivudine and Tenofovir Disoproxil Fumarate Tablets | 300 mg/300 mg | Sun Pharmaceutical Industries Ltd. | NDA | Withdrawn | Lamivudine and Tenofovir disoproxil fumarate | Tablets | No | 2-Fixed Dose Combination | Yes | Not Scored | Withdrawn 12/4/2018 Tentatively Approved 5/17/2013 | https://www.sunpharma.com/contact/usa | 160 | No | ||||||||||
| 202589 | Withdrawn | Lamivudine, Nevirapine, and Zidovudine Tablets | 150 mg/200 mg/300 mg | Macleods Pharmaceuticals Limited | NDA | Withdrawn | Lamivudine, Nevirapine, and Zidovudine | Tablets | No | 3-Fixed Dose Combination | Yes | Not Scored | Withdrawn 3/23/2023 TA'd 2/08/2012 | India | http://www.macleodspharma.com/UnitedStates.asp | 142 | No | |||||||||
| 202685 | Tentatively Approved | Lamivudine, Nevirapine and Zidovudine Tablets | 30 mg/50 mg/60 mg | Strides Pharma Global PTE Ltd | NDA | Strides Pharma Science Limited | Strides Pharma Global PTE Ltd | 09/21/2012 | HDPE bottles of 60 tablets with desiccant sachets. | Tentatively Approved | View Label | Lamivudine, Nevirapine and Zidovudine | Tablets for Oral Suspension | Strides Pharma Science Limited No 36/7, Suragajakkanahalli, Indlavadi Cross, Anekal Taluk. Bengaluru, Karnataka, India 562106 | No | 3-Fixed Dose Combination | Yes | For Pediatric patients at least 3 months of age and weighing at least 5 kg. | Do not store above 30°C (86°F). Store in the original package, protected from moisture. Keep the bottle tightlyclosed. | 24 | Scored | Tentatively Approved 9/21/2012 | India | http://www.strides.com/contact.aspx | 155 | Yes |
| 202814 | Tentatively Approved | Lamivudine and Zidovudine Tablets for Oral Suspension | 30 mg/60 mg | Cipla USA Inc. | NDA | Cipla Limited | Cipla Limited | 06/15/2012 | HDPE bottles of 60 with desiccant, induction seals, screw caps, and Child-resistant caps or Non-CRC caps.HDPE bottles of 1000 tablets with desiccant, induction seals, screw caps, and Non-CRC caps.60 tablet PVC/PE/PVDC/Aluminum blister pack cartons with | Tentatively Approved | View Label | Lamivudine and Zidovudine | Tablets for Oral Suspension | Cipla Limited Plot No. L-147 to L-147-1 (Unit VII), Verna Industrial Estate, Verna, Goa, India. 403722. | No | 2-Fixed Dose Combination | Yes | For Pediatric patients at least 3 months of age and weighing at least 5 kg. | Do not store above 30°C. | 24 | Scored | Tentatively Approved 6/15/2012 | India | https://www.cipla.com/en/contact-us.html | 150 | Yes |
| 202990 | Withdrawn | Efavirenz Tablets | 600 mg | PAR Formulations Private Ltd | ANDA | Withdrawn | Efavirenz | Tablets | No | Single | Yes | Not Scored | Withdrawn 1/10/2020 Tentatively Approved 6/25/2012 | https://www.parpharm.com/contact/ | 152 | No | ||||||||||
| 203041 | Approved | Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate Tablets | 600 mg/200 mg/300 mg | Aurobindo Pharma Limited | ANDA | Aurobindo Pharma Limited Unit - VII | Aurobindo Pharma USA, Inc. | 09/04/2018 | HDPE Bottles of 30 tablets with child resistant seal. | Approved | View Label | Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate | Tablets | Aurobindo Pharma Limited, Unit - VII, Sy. No. 411/P, 425/P, 434/P, 435/P & 458/P, Plot No. S1 (Part) SEZ (Pharma), TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahaboob Nagar (DT), Andhra Pradesh - 509 302, India. | No | 3-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 40 kg. | Store at 20 - 25°C (68 - 77°F). | 24 | Not Scored | Approved 9/4/2018 Tentatively Approved 4/2/2013 | India | https://www.aurobindousa.com/contact-us/ | 159 | Yes |
| 203053 | Approved | Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate Tablets | 600 mg/200 mg/300 mg | Hetero Labs Limited Unit V | ANDA | Hetero Labs Limited | Hetero Labs Limited Unit V | 01/25/2022 | HDPE bottles of 30 with desiccant and child-resistant closure. | Approved | View Label | Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate | Tablets | HETERO LABS LIMITED UNIT -V Sy. No.: 439, 440, 441 & 458, TSIIC Formulation SEZ Polepally Village, Jadcherla Mandal, Mahabubnagar, Telangana, India. 509301 Annora Pharma Private Limited Survey No. 261, Annaram Village, Gummadidala Mandal, Sangareddy Telangana India 502313 | No | 3-Fixed Dose Combination | Yes | For Pediatric patients 12 years of age and older who weigh at least 40 kg. | Store at 20 to 25 C (68-77 F). | 24 | Not Scored | Approved 1/25/2022 TA'd 10/31/2013 | India | https://www.heteroworld.com/contact-us.php | 164 | Yes |
| 203076 | Tentatively Approved | Lamivudine, Nevirapine and Zidovudine Tablets | 30 mg/50 mg/60 mg | Cipla Ltd | NDA | Cipla Limited | Cipla Ltd | 10/16/2012 | HDPE bottles of 60 or 1000 tablets with filler, desiccant, and induction seals. | Tentatively Approved | View Label | Lamivudine, Nevirapine and Zidovudine | Tablets for Oral Suspension | Cipla Limited., (Unit VII) Plot no. L-147, L147-1 Verna Industrial Estate, Verna, Salcette, Goa. 403722 India. | No | 3-Fixed Dose Combination | Yes | For Pediatric patients at least 3 months of age and weighing at least 5 kg. | Store below 30°C (86°F). | 24 | Scored | Tentatively Approved 10/16/2012 | India | https://www.cipla.com/en/contact-us.html | 156 | Yes |
| 203080 | Approved | Nevirapine Tablets | 200 mg | Micro Labs Limited India | ANDA | Micro Labs Limited | Micro Labs USA, Inc. | 05/22/2012 | HDPE bottles of 60.Blister packs of 10 in cartons of 60 (6X10). | Approved | View Label | Nevirapine | Tablets | Micro Labs Limited Verna Industrial Estate, Phase III & Phase IV Plot No. S-l55 to S-159 & N1 Verna, Goa, India. 403722 | No | Single | Yes | For pediatric patients at least 15 days of age or older. | Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). | 48 | Scored | Approved 5/22/2012 | India | http://www.microlabsusa.com/contactus | 146 | Yes |
| 203176 | Withdrawn | Nevirapine Tablets | 200 mg | Technology Organized LLC | ANDA | Withdrawn | Nevirapine | Tablets | No | Single | Yes | Not Scored | Withdrawn FR Effective 5/11/2018 Withdrawn 1/2/2018 Approved 5/22/2012 Tentatively Approved 4/30/2012 | http://rxtechnologist.com/contact.html | 145 | No | ||||||||||
| 203232 | Approved | Tenofovir Disoproxil Fumarate Tablets | 300 mg | Macleods Pharmaceuticals Limited | ANDA | Macleods Pharmaceuticals Limited | Macleods Pharma USA, Inc. | 01/26/2018 | HDPE bottles of 30 with desiccant. | Approved | View Label | Tenofovir Disoproxil Fumarate | Tablets | Macleods Pharmaceuticals Limited Plot No 25-27, Survey No. 366, Premier Industrial Estate, Kachigam Daman, Daman, India. 396210 | No | Single | Yes | For Pediatric patients at least 2 years of age and weighing at least 10 kg. | Store tenofovir disoproxil fumarate tablets 20 to 25°C (68 to 77 °F), excursions permitted to 15 to 30°C (59 to 86° F). | 24 | Not Scored | Approved 1/26/2018 Tentatively Approved 8/5/2014 | India | http://www.macleodspharma.com/UnitedStates.asp | 171 | Yes |
| 203283 | Withdrawn | Lamivudine and Tenofovir Disoproxil Fumarate Tablets | 300 mg/300 mg | Macleods Pharmaceuticals Ltd | NDA | Withdrawn | Lamivudine and Tenofovir disoproxil fumarate | Tablet | No | 2-Fixed Dose Combination | Yes | Not Scored | Withdrawn 3/23/2023 TA'd 11/8/2012 | India | http://www.macleodspharma.com/UnitedStates.asp | 158 | No | |||||||||
| 203442 | Approved | Emtricitabine and Tenofovir Disoproxil Fumarate Tablets | 200 mg/300 mg | Macleods Pharmaceuticals Ltd. | ANDA | Macleods Pharmaceuticals Ltd. | Macleods Pharma USA, Inc. | 05/15/2020 | HDPE Bottles of 30 or 90 Tablets with desiccant, induction seal, and child-resistant cap. HDPE Bottles of 180 Tablets with desiccant, induction seal, and non-child-resistant cap. | Approved | View Label | Emtricitabine and Tenofovir Disoproxil Fumarate | Tablets | Macleods Pharmaceuticals ltd. Plot No. 25-27, Survey No. 366, Premier Industrial Estate, Kachigam, Daman - 396210, India (IND) | No | 2-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 17 kg and can swallow a tablet. | Store below 30°C (86°F). Keep continaer tightly closed. Dispense only in original container. | 24 | Not Scored | Approved 5/15/2020 | India | http://www.macleodspharma.com/UnitedStates.asp | 226 | Yes |
| 203470 | Withdrawn | Tenofovir Disoproxil Fumarate tablets | 300 mg | Pharmacare Limited | ANDA | Withdrawn | Tenofovir Disoproxil Fumarate | Tablets | No | Single | Yes | Not Scored | Withdrawn 11/20/2018 Tentatively Approved 12/29/2019 | http://www.pharmacarelimited.com/contactus | 192 | No | ||||||||||
| 203586 | Approved | Lamivudine Tablets | 150 mg | ECI Pharmaceuticals LLC | ANDA | Centaur Pharmaceuticals Private Limited | Centaur Pharmaceuticals Private Limited | 11/21/2016 | HDPE bottle packs of 60 with 33mm child-resistant closure. | Approved | View Label | Lamivudine | Tablets | Centaur Pharmaceuticals Pvt.Ltd. Plot no. 4, International Biotech Park, Phase-II, Hinjewadi, Pune, Maharashtra 411057, India | No | Single | Yes | For Pediatric patients 3 months of age or older. | Store at 20° to 25°C (68° to 77°F) excursions permitted to 15° to 30°C (59° to 86°F). | 24 | Scored | Approved 11/21/2016 TA'd 2/10/2015 | India | http://ecipharma.com/contactus.aspx | 181 | Yes |
| 203759 | Tentatively Approved | Ritonavir Tablets | 100 mg | Cipla Ltd | ANDA | Cipla Limited | Cipla Limited | 03/27/2015 | HDPE bottle packs of 30 with 45 mm non-child-resistant closure and rayon SaniCoil. | Tentatively Approved | View Label | Ritonavir | Tablets | Cipla Limited, A-42, MIDC, Dist: Raigad, Patalgana, Maharastra, India. 410220 | No | Single | Yes | For Pediatric patients at least one month of age or older. | Store at or below 30°C (86°F). Exposure to temperatures up to 50°C (122°F) for seven days permitted.Dispense in original container or USP equivalent tight container. For patient use: exposure of this productto high humidity outside the original or USP e | 24 | Not Scored | Tentatively Approved 3/27/2015 | India | https://www.cipla.com/en/contact-us.html | 182 | Yes |
| 204119 | Tentatively Approved | Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets | 600 mg/300 mg/300 mg | Hetero Labs Limited Unit III | NDA | Hetero Labs Limited and Annora Pharma Private | Hetero Labs Limited | 06/30/2017 | HDPE bottles of 30, 90 and 100 tablets with desiccant and child resistant closure | Tentatively Approved | View Label | Efavirenz, Lamivudine, and Tenofovir disoproxil fumarate | Tablets | Annora Pharma Private Limited Survey No. 261, Annaram Village, Gummadidala Mandal Sangareddy, Telangana - 502313, India (IND). Hetero Labs Limited Unit III 22-110, I D A, Jeedimetla, Hyderabad -500 055, Andhra Pradesh, India. | No | 3-Fixed Dose Combination | Yes | For Pediatric patients greater than 40 kg. | Store below 30°C (86°F). | 24 | Not Scored | Tentatively Approved 06/30/2017 | India | https://www.heteroworld.com/contact-us.php | 157 | Yes |
| 204287 | Approved | Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate Tablets | 600 mg/200 mg/300 mg | Macleods Pharmaceuticals Limited | ANDA | Macleods Pharmaceuticals Limited | Macleods Pharma USA, Inc. | 11/28/2014 | HDPE bottle packs of 30 tablets with desiccant and child-resistant closure with pulp and heat seal liner . | Approved | View Label | Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate | Tablets, Film Coated | Macleods Pharmaceuticals Limited Plot number 25-27, Survey number 366, Premier Industrial Estate, Kachigam, Daman (Union Territory), India. 396210 Macleods Pharmaceuticals Limited Block N2, Village Theda, Post Office Lodhimajra, Tehsil Baddi, District Solan. Baddi, Himachal Pradesh, India. 174101 | No | 3-Fixed Dose Combination | Yes | For Pediatric patients at least 12 years of age and weighing at least 40 kg. | Store at 20° to 25°C (68° to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). | 24 | Not Scored | Approved 9/13/2021 TA'd 11/28/2014 | India | http://www.macleodspharma.com/UnitedStates.asp | 180 | Yes |
| 204311 | Approved | Abacavir and Lamivudine Tablets | 60 mg/30 mg | Mylan Laboratories Limited | NDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 12/22/2023 | HDPE bottles containing 60 tablets with induction seal and a child-resistant cap | Approved | View Label | Abacavir and Lamivudine | Tablets for Oral Suspension | Mylan Laboratories Limited (FDF-1), a Viatris Company F/4 and F/12 Malegaon MIDC, Sinnar Nashik Dist., Maharashtra, 422113, India | No | 2-Fixed Dose Combination | Yes | For Pediatric patients 3 months or older and weighing at least 5 kg. | Store below 30°C (86°F). Dispense in the original container and keep the container tightly closed to protect from moisture. | 24 | Scored | Approved 12/22/23,TA 10/23/14 | India | https://www.mylan.com/en/contact-mylan | 179 | Yes |
| 204396 | Tentatively Approved | Emtricitabine Capsules | 200 mg | Micro Labs Limited | ANDA | Micro Labs Limited | Micro Labs USA Inc. | 12/04/2018 | HDPE bottle packs of 30 with child-resistant closure and blister packs of 10s. | Tentatively Approved | View Label | Emtricitabine | Capsules | Micro Labs Limited Plot No: S-155 to S-159 & N1, Phase III & IV, Verna Industrial Estate, Verna, Goa - 403722. India (IND). | No | Single | Yes | For pediatric patients from 3 months through 17 years of age, who weigh more then 33 kg and who can swallow an intact capsule. | Store at 25°C (77°F) excursions permitted to 15 to 30°C (59 to 86°F). | 24 | Not Scored | Tentatively Approved 12/4/2018 | India | http://www.microlabsltd.com/contact | 216 | No |
| 204505 | Tentatively Approved | Lamivudine and Tenofovir Disoproxil Fumarate Tablets Co-packaged with Nevirapine Tablets USP | 300 mg/300 mg + 200 mg | Aurobindo Pharma Limited | NDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 10/18/2013 | Cartons of 30 day supply containing 15 blister packs each containing two one day cards, each card with two nevirapine tablets and one lamivudine/Tenofovir disoproxil fumarate tablet. | Tentatively Approved | View Label | Lamivudine/Tenofovir Disoproxil Fumarate + Nevirapine | Tablets | Aurobindo Pharma Limited, Unit-VII Sy.No. 411/P, 425/P, 434/P, 435/P & 458/P, Plot No. S1 (Part) SEZ (Pharma), APIIC, Green Industrial Park, Polepally, Mahaboob Nagar (DT), Jedcherla, Andhra Pradesh 509302, India | Yes | 3-Fixed Dose Combination | Yes | For Pediatric patients at least 16 years of age and weighing at least 35 kg. | Store below 30°C (86°F). | 24 | Not Scored | Tentatively Approved 10/18/2013 | India | https://www.aurobindousa.com/contact-us/ | 163 | No |
| 204568 | Tentatively Approved | Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets | 600 mg/300 mg/300 mg | Cipla Limited | NDA | Cipla Limited | Cipla Limited | 12/30/2013 | HDPE bottles of 30 count with non child-resistant closure | Tentatively Approved | View Label | Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate | Tablet | Cipla Limited, Plot No A-42 (Unit-II), MIDC Patalganga, 410 220, District Raigad, Maharashtra, India Cipla Limited, Unit VII Plot No.S-103 toS-105, S-107 to S-112, L-147, L-147/1 to L-147/3, L-147/A & L-138 Verna Industrial Estate, Verna, Salcette, Goa - 403 722, India Cipla Ltd. Unit VII PD II, S-103 to S-105, S-107 to S-112, L-138, L-147, L-147/1 to L-147/3, L-147 A Verna Industrial Estate, Verna Salcette, Goa- 403722, India | No | 3-Fixed Dose Combination | Yes | For Pediatric patients at least 16 years of age and weighing at least 40 kg. | Store at room temperature below 30°C (86°F). | 24 | Not Scored | Tentatively Approved 12/30/2013 | India | https://www.cipla.com/en/contact-us.html | 165 | Yes |
| 204678 | Tentatively Approved | Emtricitabine and Tenofovir Disoproxil Fumarate Tablets | 200 mg/300 mg | Micro Labs Limited | ANDA | Micro Labs Limited | Micro Labs USA Inc. | 09/21/2023 | HDPE bottles of 30 and 100 counts containing a desiccant with a child-resistant closure and blister packs of 10’s with 30 in a carton | Tentatively Approved | View Label | Emtricitabine and Tenofovir Disoproxil Fumarate | Tablets | Micro Labs Limited Plot No: S-155 to S-159 & N1, Phase III & IV, Verna Industrial Estate, Verna, Goa - 403722. India (IND). | No | 2-Fixed Dose Combination | Yes | For pediatric patients weighing at least 17 kg. | Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Keep container tightly closed. Dispense only in original container. | 24 | Not Scored | Tentatively Approved 9/21/2023 | India | https://www.microlabsusa.com/contact-us/ | 253 | Yes |
| 204739 | Tentatively Approved | Lopinavir and Ritonavir Tablets | 100 mg/25 mg, 200 mg/50 mg | Macleods Pharmaceuticals Ltd | ANDA | Macleods Pharmaceuticals Limited | Macleods Pharma USA, Inc. | 03/07/2016 | HDPE bottle packs of 60 with a child-resistant closure, heat seal linger, and silica gel sachet for 100 mg/ 25 mg dose. HDPE bottle packs of 120 , with a child-resistant closure, heat seal linger, and silica gel sachet for 200 mg/ 50 mg dose. | Tentatively Approved | View Label | Lopinavir and Ritonavir | Tablets | Macleods Pharmaceuticals Limited, Block N2, Village Theda, Post Office Lodhimajra, Tehsil Baddi, District Solan, Himachal Pradesh – 174101 India. | No | 2-Fixed Dose Combination | Yes | For Pediatric patients at least 14 days or older. | Store at 20 to 25°C (68 to 77°F). excursions permitted to 15 to 30°C (59 to 86°F). | 24 | Not Scored | Tentatively Approved 3/7/2016 | India | http://www.macleodspharma.com/UnitedStates.asp | 189 | Yes |
| 204806 | Approved | Atazanavir Capsules | 100 mg, 150 mg, 200 mg, 300 mg | Aurobindo Pharma Limited | ANDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 06/25/2018 | 100 mg: HDPE Bottles of 60 and 500. 3 X 10 Unit-dose Capsules. 150 mg: HDPE Bottles of 60, 180 and 500. 3 X 10 Unit-dose Capsules. 200 mg: HDPE Bottles of 60, 180 and 500. 3 X 10 Unit-dose Capsules. 300 mg: HDPE Bottles of 30, 90 and 500. 3 X 10 Unit-dos | Approved | View Label | Atazanavir | Capsules | Aurobindo Pharma Limited Unit-VII, Sy.No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No. S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India.509302. | No | Single | Yes | For pediatric patients at least 6 years of age and weighing at least 15 kg. | Store at 20 to 25°C (68 to 77°F). | 24 | Not Scored | Approved 6/25/2018 Tentatively Approved 1/31/2014 | India | https://www.aurobindousa.com/contact-us/ | 166 | No |
| 204914 | Tentatively Approved | Lamivudine and Zidovudine Tablets | 30 mg/60 mg | Mylan Laboratories Ltd | NDA | Mylan Laboratories Limited | Mylan Laboratories Ltd | 02/04/2014 | HDPE bottle packs of 60 tablets with desiccant. | Tentatively Approved | View Label | Lamivudine and Zidovudine | Tablet for Oral Suspension | Mylan Laboratories Limited (FDF- 2) Plot # H-12 and H-13, MIDC Waluj Industrial Area, Aurangabad- 431 136 Maharashtra, India Mylan Laboratories Limited (FDF-3) Plot No. 11, 12 and 13, Indore Special Economic Zone Pharma Zone, Phase-II, Sector-III, Pithampur Dhar district, Madhya Pradesh, India 454775 | No | 2-Fixed Dose Combination | Yes | For Pediatric patients at least 3 months of age and weighing at least 5 kg. | Store at room temperature below 30°C (86°F). | 24 | Scored | Tentatively Approved 2/4/2014 | India | https://www.mylan.com/en/contact-mylan | 167 | Yes |
| 204915 | Tentatively Approved | Abacavir Sulfate and Lamivudine Tablets for Oral Suspension | 120 mg/60 mg | Mylan Laboratories Ltd | NDA | Mylan Laboratories Limited | Mylan Laboratories Ltd | 10/23/2014 | HDPE bottle packs of 60 tablets with cotton, induction seal and child-resistant cap. | Tentatively Approved | View Label | Abacavir Sulfate and Lamivudine | Tablets for Oral Suspension | Mylan Laboratories Limited (FDF-2) Plot No. H-12 & H-13, MIDC Waluj, Aurangabad - 431136 Maharashtra, India Mylan Laboratories Limited (FDF-3) Plot No. 11, 12 &13, Indore Special Economic Zone Pharma Zone, Phase-II, Sector-III, Pithampur Dhar district, Madhya Pradesh, India, 454775 | No | 2-Fixed Dose Combination | Yes | For Pediatric patients 3 months or older. | Store at room temperature below 30°C (86°F). | 24 | Scored | Tentatively Approved 10/23/2014 | India | https://www.mylan.com/en/contact-mylan | 178 | Yes |
| 205040 | Tentatively Approved | Ritonavir Tablets | 25 mg, 50 mg | Cipla Ltd | NDA | Cipla Limited | Cipla Ltd | 03/29/2015 | HDPE bottles containing 60 tablets, with non child-resistant closure | Tentatively Approved | View Label | Ritonavir | Tablets | Cipla Limited., Unit II, A-42, MIDC, Patalganga , District Raigad, Maharashtra, India. 410220 | No | Single | Yes | For Pediatric patients at least 3 years of age or older. | Store below 30°C (86°F). | 24 | Not Scored | Tentatively Approved 3/29/2015 | India | https://www.cipla.com/en/contact-us.html | 183 | Yes |
| 205302 | Tentatively Approved | Rilpivirine Tablets | 25 mg | Strides Pharma Global PTE Ltd | ANDA | Strides Pharma Science Limited | Strides Pharma Inc. | 09/29/2015 | HDPE bottle packs of 30 tablets with 33 mm child-resistant closure. | Tentatively Approved | View Label | Rilpivirine | Tablets | Strides Pharma Science Limited No 36/7, Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bengaluru, Karnataka, India. 562106 | No | Single | Yes | For Pediatric patients 12 years of age or older and at least 35 kg. | Store tablets at 25°C (77°F); with excursions permitted to 15-30°C (59-86°F). | 24 | Not Scored | Tentatively Approved 9/29/2015 | India | http://www.strides.com/contact.aspx | 186 | No |
| 205355 | Tentatively Approved | Lamivudine and Tenofovir Disoproxil Fumarate Tablets, co-packaged with Nevirapine Tablets | 300 mg/300 mg + 200 mg | Hetero Labs Ltd Unit III | NDA | Hetero Labs Limited Unit III | Hetero Labs Ltd Unit III | 03/14/2014 | Cartons of 10 single-day blister cards each blister card containing one tablet tenofovir disoproxil fumarate/lamivudine and two tablets of nevirapine. (Alu-Alu with desiccant)(3X10). | Tentatively Approved | View Label | Lamivudine and Tenofovir Disoproxil Fumarate Tablets, co-packaged with Nevirapine Tablets | Tablets | Hetero Labs Limited Unit III Plot No. 22-110, Part-II, Industrial Development Area Jeedimetla, Hyderabad, Telangana, India 500055 | Yes | 4-Fixed Dose Combination | Yes | For Adolescents patients at least 16 years of age and weighing at least 35 kg. | Store at room temperature below 30°C (86°F). | 24 | Not Scored | Tentatively Approved 3/14/2014 | India | https://www.heteroworld.com/contact-us.php | 169 | No |
| 205389 | Tentatively Approved | Efavirenz Tablets | 50 mg, 100 mg, 200 mg | Micro Labs Limited India | NDA | Micro Labs Limited | Micro Labs USA , Inc. | 02/23/2018 | HDPE bottles containing 30 or 90 tablets with induction seal and child-resistant cap.Cartons containing 100 unit-dose tablets in 10 PVC aluminum foil blister cards. | Tentatively Approved | View Label | Efavirenz | Tablets | Micro Labs Limited Plot No: S-155 to S-159, Phase III, Verna Industrial Estate, Verna, Goa- 403722 | No | Single | Yes | For Pediatric patients at least three months old and weighing at least 3.5 kg. | Store below 30°C (86°F). | 36 | Not Scored | Tentatively Approved 2/23/2018 | India | http://www.microlabsusa.com/contactus | 207 | Yes |
| 205412 | Tentatively Approved | Abacavir Sulfate and Lamivudine Tablets | 600 mg/300 mg | Hetero Labs Limited Unit V | ANDA | Hetero Labs Limited Unit V | Hetero Labs Limited Unit V | 09/25/2014 | HDPE bottles of 30 with child-resistant caps, pulp liners, and desiccant. | Tentatively Approved | View Label | Abacavir Sulfate and Lamivudine | Tablets | Hetero Labs Limited Unit V Sy. No.: 439, 440, 441 & 458, TSIIC Formulation SEZ Polepally Village, Jadcherla Mandal, Mahabubnagar, Telangana, India. 509301 | No | 2-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 25 kg. | Store at 20 to 25°C (68° to 77°F). | 24 | Not Scored | Tentatively Approved 9/25/2014 | India | https://www.heteroworld.com/contact-us.php | 177 | Yes |
| 205425 | Tentatively Approved | Lopinavir and Ritonavir Oral Pellets | 40 mg/10 mg | Cipla Ltd | NDA | Cipla Ltd | Cipla Ltd | 05/21/2015 | HDPE bottles of 120 capsules containing the oral pellets, with desiccant, induction seal, and non-child-resistant closure | Tentatively Approved | View Label | Lopinavir and Ritonavir | Oral Pellets | Cipla Limited (Unit VII) Plot No. L-147 - L147-1, Verna Industrial Estate. Verna, Salcette, Goa 403 722, India. | No | 2-Fixed Dose Combination | Yes | For Pediatric patients with a postmenstrual age (first day of the mother’s last menstrual period to birth plus the time elapsed after birth) of 42 weeks and a postnatal age of at least 14 days. | Store at room temperature below 30°C (86°F). For patient use: exposure of this product to highhumidity outside the original container for longer than 2 weeks is not recommended. | 24 | Not Scored | Tentatively Approved 5/21/2015 | India | https://www.cipla.com/en/contact-us.html | 184 | Yes |
| 205493 | Tentatively Approved | Lamivudine and Tenofovir Disoproxil Fumarate Tablets | 300 mg/300 mg | Micro Labs Limited India | NDA | Micro Labs Limited India | Micro Labs USA. Inc. | 01/25/2018 | HDPE bottles containing 30 or 100 tablets with induction seal, desiccant, cotton coil, and child-resistant cap | Tentatively Approved | View Label | Lamivudine and Tenofovir Disoproxil Fumarate | Tablets | Micro Labs Limited Plot No: S-155 to S-159, Phase III, Verna Industrial Estate, Verna, Goa - 403 722, India | No | 2-Fixed Dose Combination | Yes | For Pediatric patients at least 12 years of age or weighing at least 35 kg. | Store below 30°C (86°F). | 24 | Not Scored | Tentatively Approved 1/25/2018 | India | http://www.microlabsusa.com/contactus | 205 | No |
| 205508 | Tentatively Approved | Atazanavir Sulfate and Ritonavir Tablets | 300 mg/100 mg | Emcure Pharmaceuticals Ltd | NDA | Emcure Pharmaceuticals Limited | Heritage Pharmaceuticals Inc. | 03/17/2014 | HDPE bottles of 30-count with desiccant and induction sealed child-resistant closure. | Tentatively Approved | View Label | Atazanavir Sulfate and Ritonavir | Tablets | Emcure Pharmaceuticals Limited Plot No. P-2, I.T.B.T. Park, Phase-II, MIDC, Hinjawadi Pune, Maharashtra, India. 411057. | Yes | 2-Fixed Dose Combination | Yes | For Pediatric patients at least 6 years of age and weighing at least 40 kg. | Store at room temperature below 30°C (86°F). | 36 | Not Scored | Tentatively Approved 3/17/2014 | India | https://emcure.com/contactus | 170 | Yes |
| 205626 | Approved | Lamivudine, Nevirapine, and Zidovudine fixed dose combination Tablets | 150 mg/200 mg/300 mg | Micro Labs Limited | NDA | Micro Labs Limited | Micro Labs USA Inc. | 08/13/2018 | HDPE bottles containing 60 tablets with induction seal and child-resistant closure. | Approved | View Label | Lamivudine, Nevirapine, and Zidovudine | Tablets | Micro Labs Limited Plot No: S-155 to S-159 & N1, Phase III & IV, Verna Industrial Estate, Verna, Goa - 403722. India (IND). | No | 3-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 35 kg. | Store below 30°C (86°F). Store in tight, light-resistant containers. | 24 | Not Scored | Approved 8/13/2018 | India | http://www.microlabsusa.com/contactus | 214 | No |
| 205861 | Withdrawn | Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets | 600 mg/300 mg/300 mg | Macleods Pharmaceuticals Ltd | NDA | Withdrawn | Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate | Tablets | No | 3-Fixed Dose Combination | Yes | Not Scored | Withdrawn Effective 2/11/2021 Tentatively Approved 8/14/2014 | http://www.macleodspharma.com/UnitedStates.asp | 172 | No | ||||||||||
| 205921 | Tentatively Approved | Nevirapine Extended-Release Tablets | 400 mg | Mylan Laboratories Limited | ANDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 08/26/2014 | HDPE bottle, 30’s, cotton, CR and Non-CR caps with induction seals. | Tentatively Approved | View Label | Nevirapine | Extended-release Tablets | Mylan Laboratories Limited (FDF-1) Plot # F-4 and F-12 Malegaon MIDC, Sinnar Nashik District, Maharashtra, India. 422113 | No | Single | Yes | For Pediatric patients at least 6 years of age. | Store at 20 to 25°C (68 to 77°F). | 24 | Not Scored | Tentatively Approved 8/26/2014 | India | https://www.mylan.com/en/contact-mylan | 173 | No |
| 206040 | Withdrawn | Lamivudine and Zidovudine Tablets, Co-packaged with Efavirenz Tablets | 150 mg/300 mg + 600 mg | Mylan Laboratories Ltd | NDA | Withdrawn | Lamivudine and Zidovudine Tablets, Co-packaged with Efavirenz Tablets | Tablets | No | 4-Fixed Dose Combination | Yes | Not Scored | Withdrawn Effective 4/6/2017 Tentatively Approved 9/4/2014 | https://www.mylan.com/en/contact-mylan | 174 | No | ||||||||||
| 206041 | Withdrawn | Atazanavir Sulfate and Ritonavir Tablets, co-packaged with Lamivudine and Zidovudine Tablets | 300 mg/100 mg + 150 mg/300 mg | Mylan Laboratories Ltd | NDA | Withdrawn | Atazanavir Sulfate and Ritonavir Tablets, co-packaged with Lamivudine and Zidovudine Tablets | Tablets | No | 4-Fixed Dose Combination | Yes | Not Scored | Withdrawn 4/6/2017 Tentatively Approved 9/4/2014 | https://www.mylan.com/en/contact-mylan | 175 | No | ||||||||||
| 206042 | Withdrawn | Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, Co-packaged with Nevirapine Tablets | 200 mg/300 mg + 200 mg | Mylan Laboratories Ltd | NDA | Withdrawn | Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, Co-packaged with Nevirapine Tablets | Tablets | No | 4-Fixed Dose Combination | Yes | Not Scored | Withdrawn Effective 4/6/2017 Tentatively Approved 9/12/2014 | https://www.mylan.com/en/contact-mylan | 176 | No | ||||||||||
| 206375 | Approved | Lamivudine and Zidovudine Tablets | 150 mg/300 mg | Shanghai Desano Bio-Pharmaceutical Co., Ltd | ANDA | Shanghai Desano Bio-Pharmaceutical Co., Ltd | Shanghai Desano Bio-Pharmaceutical Co., Ltd | 04/10/2018 | HDPE bottles containing 60 tablets. | Approved | View Label | Lamivudine and Zidovudine | Tablets | Shanghai Desano Bio-Pharmaceutical Co., Ltd. 1479 Zhangheng Road Zhangjiang High-tech Park Shanghai 201203, P.R.China | No | 2-Fixed Dose Combination | Yes | For pediatric patients weighing greater than or equal to 30 kg. | Store at 20° to 25°C (68° to 77°F). | 24 | Scored | Approved 4/10/2018 | China | http://www.desano.com/en/contact.php | 210 | Yes |
| 206451 | Tentatively Approved | Atazanavir and Ritonavir tablets | 300 mg/100 mg | Cipla Limited | NDA | Cipla Limited | Cipla Limited | 10/27/2017 | HDPE bottles containing 30 tablets with desiccant and non child-resistant cap and aluminum-aluminum blister packs containing 100 tablets (10 blister packs of 10 tablets each). | Tentatively Approved | View Label | Atazanavir and Ritonavir | Tablets | Cipla Ltd. Plot No A – 42 (Unit II), MIDC, Patalganga, District Raigad, Maharashtra, Pin code: 410 220. India. | No | 2-Fixed Dose Combination | Yes | For Pediatric patients at least 6 years of age and weighing 35 kg or greater. | Store below 30°C (86°F). | 24 | Not Scored | Tentatively Approved 10/27/2017 | India | https://www.cipla.com/en/contact-us.html | 201 | Yes |
| 206725 | Tentatively Approved | Abacavir Sulfate Tablets | 300mg | Micro Labs Ltd India | ANDA | Micro Labs Limited | Micro Labs USA Inc. | 12/22/2017 | HDPE bottle packs of 60 with child-resistant closure and blister packs of 10's. | Tentatively Approved | View Label | Abacavir Sulfate | Tablets | Micro Labs limited, S-155-159, Verna Industrial Estate, Venra, Goa 403722, India | No | Single | Yes | For pediatric patients aged 3 months or older. | Store at controlled room temperature of 20 to 25°C (68 to 77°F). | 24 | Scored | Tentatively Approved 12/22/2017 | India | http://www.microlabsltd.com/contact | 204 | No |
| 207064 | Tentatively Approved | Nevirapine Extended-Release Tablets | 400 mg | Cipla Limited | ANDA | Cipla Limited | Cipla Limited | 06/30/2015 | HDPE bottles of 30 with child-resistant cap. HDPE bottle of 480. Blister cartons of 50 (5X10). | Tentatively Approved | View Label | Nevirapine | Tablets, Extended-Release | Cipla Limited Goa Plot No. L-147- 147/1 (Unit VII) Verna Industrial Estate Verna, Goa India. -403722 | No | Single | Yes | For Pediatric patients at least 6 years of age with a body surface area (BDA) of 1.17m2. | Store tablets at 25C (77°F); with excursions permitted to 15-30°C (59-86°F). | 24 | Not Scored | Tentatively Approved 6/30/2015 | India | https://www.cipla.com/en/contact-us.html | 185 | Yes |
| 207189 | Tentatively Approved | Darunavir Tablets | 75 mg, 150 mg, 400 mg, 600 mg | Cipla Limited | ANDA | Cipla Limited | Cipla Limited | 03/16/2017 | HDPE bottle packs of 480 with a non-child-resistant closure for the 75 mg tablets, HDPE bottle packs of 240 with a non-child-resistant closure for the 150 mg tablets, HDPE bottle packs of 60 with a non-child-resistant closure for the 400 mg and 600 mg tab | Tentatively Approved | View Label | Darunavir | Tablets | Cipla Limited, Plot no a-33, a-42, a-2, Patalganga Industrial Area, Patalganga District - Raigad, Maharashtra IN 410220 | No | Single | Yes | For Pediatric patients three years of age or older and weighing at least 10 kg. | Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). | 24 | Not Scored | Tentatively Approved 3/16/2017 | India | https://www.cipla.com/en/contact-us.html | 194 | Yes |
| 207315 | Withdrawn | Lamivudine and Tenofovir Disoproxil Fumarate Tablets | 75 mg/75 mg | Hetero Labs Limited Unit III | NDA | Withdrawn | Lamivudine and Tenofovir Disoproxil Fumarate | Tablets | No | 2-Fixed Dose Combination | Yes | Not Scored | Withdrawn 10/24/2019 Tentatively Approved 5/5/2017 | https://www.heteroworld.com/contact-us.php | 196 | No | ||||||||||
| 207369 | Tentatively Approved | Abacavir and Lamivudine Tablets | 60 mg/30 mg | Hetero Labs Ltd Unit V | NDA | Hetero Labs Limited Unit V | Hetero Labs Ltd Unit V | 11/13/2015 | HDPE bottles containing 30 tablets with desiccant (silica gel), pulp liner, and child-resistant closure. Blister card of 10 unit dose tablets and cartons of 10 blisters with each blister pack containing 10 doses (100 unit doses total). | Tentatively Approved | View Label | Abacavir and Lamivudine | Tablets | Hetero Labs Limited Unit V Sy. No.: 439, 440, 441 & 458, TSIIC Formulation SEZ Polepally Village, Jadcherla Mandal Mahabubnagar, Telangana. India 509301. | No | 2-Fixed Dose Combination | Yes | For Pediatric patients at least three months of age. | Store below 30°C (86°F). | 24 | Scored | Tentatively Approved 11/13/2015 | India | https://www.heteroworld.com/contact-us.php | 187 | No |
| 207684 | Approved | Nevirapine Oral Suspension | 50 mg/5 mL | Cipla Ltd | ANDA | Cipla Ltd | Cipla USA Inc. | 08/03/2017 | HDPE bottles with child resistant closure and liner containing 100 or 240 mL of suspension along with oral syringe. | Approved | View Label | Nevirapine | Oral Suspension | Unit 1, Plot No.9, 10 & 15 Indore Special Economic Zone, Phase II Pithampur, District Dhar, Pin Code: 454775. Madhya Pradesh, India. | No | Single | Yes | For Pediatric patients at least 15 days of age. | Store at 25°C (77°F); excursions permitted to 15-30°C. | 24 | Not Scored | Approved 8/3/2017 | India | https://www.cipla.com/en/contact-us.html | 199 | Yes |
| 207892 | Withdrawn | Emtricitabine and Tenofovir Disoproxil Fumarate Tablets | 200 mg/300 mg | Pharmacare Limited | ANDA | Withdrawn | Emtricitabine and Tenofovir Disoproxil Fumarate | Tablets | No | 2-Fixed Dose Combination | Yes | Not Scored | Withdrawn 1/3/2019 Tentatively Approved 4/24/2018 | http://www.pharmacarelimited.com/contactus | 211 | No | ||||||||||
| 207895 | Withdrawn | Efavirenz Tablets | 600 mg | Pharmacare Limited | ANDA | Withdrawn | Efavirenz | Tablets | No | Single | Yes | Not Scored | Withdrawn 11/20/2018 Tentatively Approved 5/19/2017 | http://www.pharmacarelimited.com/contactus | 197 | No | ||||||||||
| 208255 | Approved | Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets | 400 mg/300 mg/300 mg | Mylan Pharmaceuticals Inc. | NDA | Mylan Laboratories Limited | Mylan Specialty L.P. | 02/05/2018 | HDPE bottles of 30 tablets with desiccant, induction seal, and child-resistant cap. | Approved | View Label | Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate | Tablets | Mylan Laboratories Limited (FDF-2) Plot No. H-12 & H-13, MIDC, Waluj, Aurangabad, Maharashtra, India 431136 Mylan Laboratories Limited (FDF-3) Mylan Laboratories Limited Plot No. 11, 12, and 13, Indore SEZ Pharma Zone, Phase -II, sector -III, Pithampur- 454775, Dhar, Madya Pradesh, India | No | 3-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 35 kg. | Store below 30°C (86°F). | 36 | Not Scored | Approved 2/05/2018 Tentatively Approved 03/10/201 | India | https://www.mylan.com/en/contact-mylan | 193 | Yes |
| 208355 | Tentatively Approved | Dolutegravir Tablets | 50 mg | Aurobindo Pharma Limited | ANDA | Aurobindo Pharma Unit-VII | Aurobindo Pharma USA, Inc. | 09/19/2016 | HDPE bottles of 30 and 90 with child resistant enclosure. | Tentatively Approved | View Label | Dolutegravir | Tablets | Aurobindo Pharma Limited Unit-VII, Sy.No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No. S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana. India 509302. APL Healthcare Limited Unit-IV Plot No.16, APIIC, M.P. SEZ, Menakuru Village, Naidupeta Mandal, Tirupati District Andhra Pradesh, 524421 - India | No | Single | Yes | For Pediatric patients weighing at least 30 kg. | Store below 30°C (86°F). | 24 and 36 | Not Scored | Tentatively Approved 9/19/2016 | India | https://www.aurobindousa.com/contact-us/ | 191 | Yes |
| 208656 | Tentatively Approved | Abacavir Tablets for Oral Suspension | 60 mg | Micro Labs limited India | NDA | Micro Labs limited | Micro Labs Limited USA | 11/28/2017 | HDPE bottles containing 60 tablets with desiccant, induction seal, filler, and child-resistant cap | Tentatively Approved | View Label | Abacavir | Tablets for Oral Suspension | Micro Labs Limited Plot No: S-155 to S-159 & N1, Phase III & Phase IV, Verna Industrial Estate, Verna, Goa- 403722. India (IND). | No | Single | Yes | For Pediatric patients three months and older weighing at least 5 kg. | Store below 30°C (86°F). | 24 | Scored | Tentatively Approved 11/28/2017 | India | http://www.microlabsusa.com/contactus | 202 | No |
| 208775 | Tentatively Approved | Abacavir and Lamivudine Tablets for Oral Suspension | 120 mg/60 mg | Cipla Limited | NDA | Cipla Limited | Cipla Limited | 04/06/2017 | HDPE bottle of 60 tablets containing a desiccant and an induction seal, and closed with a child-resistant capHDPE bottle of 30 tablets containing a desiccant and an induction seal, and closed with a non-child-resistant cap | Tentatively Approved | View Label | Abacavir and Lamivudine | Tablets for Oral Suspension | Cipla Ltd, Plot No A - 33, A - 2 (Unit - I), MIDC, Patalganga District Raigad, Maharashtra, 410 220 India | No | 2-Fixed Dose Combination | Yes | For Pediatric patients three months or older and weighing at least 6 kg. | Store below 30°C (86°F). | 36 | Scored | Tentatively Approved 04/06/2017 | India | https://www.cipla.com/en/contact-us.html | 195 | Yes |
| 209550 | Approved | Tenofovir Disoproxil Fumarate Tablets | 300 mg | Casi Pharmaceuticals Inc. | ANDA | Laurus Labs Limited | Laurus Generics Inc. | 02/26/2018 | HDPE bottles of 30 with child resistant closure and desiccant. HDPE bottles of 500 with desiccant. | Approved | View Label | Tenofovir Disoproxil Fumarate | Tablets | Laurus Labs Private Limited (Unit 2), Plot No. 19, 20 and 21, Western Sector, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh 531011, India. | No | Single | Yes | For Pediatric patients over two years of age. | Store at 20 to 25°C (68 to 77°F); excursions permitted between 15 to 30°C (59 to 86°F). Keep bottle tightly closed. | 36 | Not Scored | Approved 2/26/2018 Tentatively Approved 11/29/2017 | India | http://www.casipharmaceuticals.com/about-us/contact-us/ | 203 | No |
| 209565 | Tentatively Approved | Dolutegravir Tablets | 50 mg | Hetero Labs Limited Unit-III | ANDA | Hetero Labs Limited Unit-III | Hetero Labs Limited | 09/29/2020 | HDPE Bottles of 30 tablets with child-resistant cap. Cartons of 80 unit doses in 10 dose blister packs (8X10). | Tentatively Approved | View Label | Dolutegravir | Tablets | Hetero Labs Limited Unit III Plot No. 22 – 110, Part-II, Industrial Development Area, Jeedimetla, Hyderabad, Telangana, India 500055 | No | Single | Yes | For Pediatric patients weighing at least 14 kg. | Store below 30°C (86°F). | 48/36 | Not Scored | Tentatively Approved 9/29/2020 | India | https://www.heteroworld.com/contact-us.php | 227 | Yes |
| 209602 | Tentatively Approved | Dolutegravir Tablets | 50 mg | Mylan Laboratories Ltd | ANDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 07/06/2018 | HDPE bottle packs of 30 with non-child-resistant closure | Tentatively Approved | View Label | Dolutegravir | Tablets | Mylan Laboratories Limited (FDF-3) Plot No. 11, 12 & 13 Indore Special Economic Zone Pharma Zone, Phase II Sector III, Pithampur, District Dhar - 454775, Madhya Pradesh, India | No | Single | Yes | For Pediatric patients weighing at least 30 kg. | Store at 20° to 25°C (68° to 77°F) | 24 | Not Scored | Tentatively Approved 7/6/2018 | India | https://www.mylan.com/en/contact-mylan | 212 | Yes |
| 209618 | Tentatively Approved | Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets | 50 mg/300 mg/300 mg | Aurobindo Pharma Limited | NDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 08/18/2017 | HDPE bottles of 30, 90 and 180's tablets with desiccant, induction seal and child resistant cap. | Tentatively Approved | View Label | Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate | Tablets | Aurobindo Pharma Limited Unit-VII Sy.No. 411/P, 425/P, 434/P, 435/P & 458/P, Plot No. S1 (Part) SEZ (Pharma), TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabub Nagar (District), Mahabub Nagar, Telangana -509302, India APL Healthcare Limited, Unit-IV Plot No.16, APIIC Multi Product SEZ, Menakuru, Naidupeta, S.P.S.R Nellore, Andhra Pradesh, 524421 India | No | 3-Fixed Dose Combination | Yes | For Pediatric patients at least 12 years of age and weighing 40 kg or greater. | Store below 30°C (86°F). | 24 | Not Scored | Tentatively Approved 8/18/2017 | India | https://www.aurobindousa.com/contact-us/ | 200 | Yes |
| 209658 | Tentatively Approved | Dolutegravir Tablets | 50 mg | Cipla Limited | ANDA | Cipla Limited | Cipla Limited | 03/05/2018 | Bottles of 30, 90, and 100 with child-resistant closure and bottles of 500 with non-child-resistant closure | Tentatively Approved | View Label | Dolutegravir | Tablets | Cipla Limited Unit IV, Plot No. 9, 10 &15 Indore Special Economic Zone, Phase II, Pithampur, District Dhar, Pin Code: 454775. Madhya Pradesh, India. | No | Single | Yes | For weighing Pediatric patients weighing at least 40 kg. | Store at 25°C (77°F); excursions permitted between 15 to 30°C (59 to 86°F). | 24 | Not Scored | Tentatively Approved 3/5/2018 | India | https://www.cipla.com/en/contact-us.html | 208 | Yes |
| 209670 | Tentatively Approved | Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets | 50 mg/300 mg/300 mg | Mylan Laboratories Limited | NDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 08/02/2017 | HDPE bottles containing 30, 90, or 180 tables with desiccant, induction seal, and non-child-resistant cap. | Tentatively Approved | View Label | Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate | Tablets | Mylan Laboratories Limited (FDF-3) Plot No. 11, 12 and 13, Indore Special Economic Zone Pharma Zone, Phase II, Sector III Pithampur , District Dhar - 454775 Madhya Pradesh, India | No | 3-Fixed Dose Combination | Yes | For Pediatric patients at least 12 years of age and weighing 40 kg or greater. | Store below 30°C (86°F). Keep bottle tightly closed. Dispense only in original container. | 24 | Not Scored | Tentatively Approved 8/2/2017 | India | https://www.mylan.com/en/contact-mylan | 198 | Yes |
| 209847 | Tentatively Approved | Darunavir and Ritonavir | 400 mg/50 mg | Mylan Laboratories Limited | NDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 12/22/2023 | HDPE bottles containing 60 tablets fitted with screw closures and induction seals and containing desiccant | Tentatively Approved | View Label | Darunavir and Ritonavir | Tablets | Mylan Laboratories Limited (FDF-1), a Viatris Company F/4 and F/12 Malegaon, MIDC, Sinnar, Nasik District Nashik, Maharashtra – 422113, India | No | 2-Fixed Dose Combination | Yes | For pediatric patients weighing at least 40 kg. | Store below 30°C (86°F). Store in the original bottle, protect from moisture, and keep bottle tightly closed. Do not remove desiccant. | 24 | Not Scored | Tentatively Approved 12/22/2023 | India | https://www.mylan.com/en/contact-mylan | 254 | Yes |
| 210187 | Tentatively Approved | Darunavir Tablets | 150 mg, 400 mg, 600 mg | Micro Labs Ltd. | ANDA | Micro Labs Ltd. | Micros Labs USA, Inc. | 12/14/2020 | HDPE bottles of 60 tablets with desiccant and child-resistant cap of the 150 mg, 400 mg, and 600 mg strengths.HDPE bottles of 120 tablets with desiccant and child-resistant cap of the 150 mg strength.HDPE bottles of 240 tablets with desiccant and scre | Tentatively Approved | View Label | Darunavir | Tablets | Micro Labs Limited Plot No. S-155 to S-159 & N1, Phase III & Phase IV Verna Industrial Estate, Verna, Goa, India. 403722. | No | Single | Yes | For Pediatric patients at least 3 years of age and weighing at least 10kg. | Store at 25°C (77°F); with excursions permitted between 15° to 30°C (59° to 86°F). | 24 | Not Scored | Tentatively Approved 12/14/2020 | India | http://www.microlabsusa.com/contactus | 231 | Yes |
| 210237 | Tentatively Approved | Dolutegravir, Emtricitabine, and Tenofovir Alafenamide Tablets | 50 mg/200 mg/25 mg | Mylan Laboratories Limited | NDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 02/09/2018 | HDPE bottles of 30 and 90 with desiccant, induction seal, and non-child resistant cap. | Tentatively Approved | View Label | Dolutegravir, Emtricitabine and Tenofovir Alafenamide | Tablets | Mylan Laboratories Limited (FDF-3) Plot No. 11, 12 & 13, Indore Special Economic Zone, Pharma Zone, Phase - II, Sector - III, Pithampur, District Dhar - 454775, Madhya Pradesh, India. | No | 3-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 40 kg. | Store below 30°C (86°F). | 24/18 | Not Scored | Tentatively Approved 2/9/2018 | India | https://www.mylan.com/en/contact-mylan | 206 | No |
| 210254 | Tentatively Approved | Darunavir Tablets | 800 mg | Cipla Limited | ANDA | Cipla Limited | Cipla Limited | 03/14/2018 | HDPE bottles of 30 with child resistant closure and non child resistant screw. | Tentatively Approved | View Label | Darunavir | Tablets | Cipla Limited, Plot no a-33, a-42, a-2, Patalganga Industrial Area, Patalganga District - Raigad, Maharashtra IN 410220 | No | Single | Yes | For Pediatric patients three years of age or older and weighing at least 10 kg. | Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). | 24 | Not Scored | Tentatively Approved 3/14/2018 | India | https://www.cipla.com/en/contact-us.html | 209 | Yes |
| 210540 | Tentatively Approved | Lopinavir and Ritonavir Oral Granules | 40 mg/10 mg | Mylan Laboratories Limited | NDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 08/16/2018 | Cartons containing 120 aluminum foil sachets. | Tentatively Approved | View Label | Lopinavir and Ritonavir | Oral Granules | Mylan Laboratories Limited (FDF-1) Plot No. F/4 and F/12, Malegaon MIDC Sinnar, Nashik District - 422113, Maharashtra, India | No | 2-Fixed Dose Combination | Yes | For Pediatric patients 14 days or older. | Store below 30°C (86°F). This sachet is not child-resistant. Dispense in original container. | 24 | Not Scored | Tentatively Approved 8/16/2018 | India | https://www.mylan.com/en/contact-mylan | 215 | Yes |
| 210642 | Tentatively Approved | Abacavir, Dolutegravir, and Lamivudine Tablets | 600 mg/50 mg/300 mg | Aurobindo Pharma Limited | ANDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 05/12/2023 | HDPE bottles of 30 tablets with desiccant and child-resistance closures | Tentatively Approved | View Label | Abacavir, Dolutegravir, and Lamivudine | Tablets | APL Healthcare Limited Unit-IV Plot No.16, APIIC, M.P. SEZ, Menakuru Village, Naidupeta Mandal, Tirupati District Andhra Pradesh, 524421 - India | No | 3-Fixed Dose Combination | Yes | For pediatric patients weighing at least 25 kg | Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). Store and dispense in the original package, protect from moisture, and keep the bottle tightly closde. Do not remove desiccant. | 24 | Not Scored | Tentatively Approved 5/12/2023 | India | http://www.aurobindousa.com/contact-us/ | 244 | Yes |
| 210649 | Approved | Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets | 400 mg/300 mg/300 mg | Macleods Pharmaceuticals Ltd. | NDA | Macleods Pharmaceuticals Ltd. | Macleods Pharma USA Inc. | 03/15/2019 | HW HDPE bottles containing 30 or 90 with desiccant, induction seal, and child resistant caps. HW HDPE bottles of 180 with desiccant and induction seal. | Approved | View Label | Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate | Tablets | Macleods Pharmaceuticals Limited Survey No 366, Premier Industrial Estate, Kachigam Plot No. 25 - 27 Daman, Daman, India.396210. | No | 3-Fixed Dose Combination | Yes | Approved for use in pediatrics patients with a weight greater than 35 kg. | Store below 30°C (86°F). Store in original bottle, protect from moisture, and keep bottle tightly closed. Do not remove desiccant. Keep out of reach of children. | 24 | Not Scored | Approved 3/15/2019 | India | http://www.macleodspharma.com/UnitedStates.asp | 218 | Yes |
| 210787 | Tentatively Approved | Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets | 50 mg/300 mg/300 mg | Laurus Labs Limited | NDA | Laurus Labs Limited | Laurus Generics Inc. | 02/01/2019 | HDPE bottles containing 30 or 90 tablets with desiccant, induction seal, and child-resistant capHDPE bottles containing 30, 90, or 180 tablets with desiccant, induction seal, and non-child-resistant cap | Tentatively Approved | View Label | Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate | Tablets | Laurus Labs Limited, Plot No. 19, 20, and 21, Western Sector, APSEZ, Atchutapuram, Visakhapatnam -531011, Andhra Pradesh, India | No | 3-Fixed Dose Combination | Yes | Pediatric patients weighing at least 35 kg. | Store below 30°C (86°F). Store in original bottle, protect from moisture, and keep bottle tightly closed. Do not remove desiccant. Keep out of reach of children. | 36 | Not Scored | Tentatively Approved 2/1/2019 | India | http://www.lauruslabs.com/contact-us | 217 | Yes |
| 210796 | Tentatively Approved | Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets | 50 mg/300 mg/300 mg | Macleods Pharmaceuticals Ltd. | NDA | Macleods Pharmaceuticals Ltd. | Macleods Pharma USA Inc. | 03/25/2019 | HW HDPE bottles containing 30, 90 or 180 tablets with desiccant, induction seals, and non child-resistant caps. | Tentatively Approved | View Label | Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate | Tablets | Macleods Pharmaceuticals Limited, Plot No. 25-27, Survey No. 366, Premier Industrial Estate, Kachigam, Daman - 396210, India Macleods Pharmaceuticals Limited, Plot no: M-50 to M-54A, SEZ, Phase-II, Pithampur, Tehsil- Patera Dhar, Madhya Pradesh - 454774, India | No | 3-Fixed Dose Combination | Yes | Approved for use in pediatrics patients with a weight greater than 35 kg. | Store below 30°C (86°F). Store in original bottle, protect from moisture, and keep bottle tightly closed. Do not remove desiccant. | 24 | Not Scored | Tentatively Approved 3/25/2019 | India | http://www.macleodspharma.com/UnitedStates.asp | 219 | Yes |
| 210865 | Tentatively Approved | Dolutegravir, Lamivudine, and Tenofovir Alafenamide Tablets | 50 mg/300 mg/25 mg | Mylan Laboratories Ltd. | NDA | Mylan Laboratories Limited | Mylan Laboratories Ltd. | 09/11/2019 | HDPE bottles of 30, 60, and 180 tablets with desiccant, induction seal, and non-child-resistant cap. | Tentatively Approved | View Label | Dolutegravir, Lamivudine and Tenofovir Alafenamide | Tablets | Mylan Laboratories Limited (FDF-3) Plot No. 11, 12 & 13, Indore Special Economic Zone Pharma Zone, Phase - II, Sector - III, Pithampur District Dhar, Madhya Pradesh, India 454775 | No | 3-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 40 kg. | Store below 30°C (86°F). | Not Scored | Tentatively Approved 9/11/2019 | India | https://www.mylan.com/en/contact-mylan | 221 | Yes | |
| 210880 | Tentatively Approved | Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets | 50 mg/300 mg/300 mg | Hetero Labs Unit III | NDA | Hetero Labs Limited and Annora Pharma Private Ltd | Hetero Labs Limited | 08/08/2018 | HDPE Bottles of 30, 60, 90, 100, 180 or 750 tablets with desiccant, induction seals and child resistant closures. | Tentatively Approved | View Label | Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate | Tablets | Hetero Labs Limited Unit-III, 22-110, I.D.A, Jeedimetla, Hyderabad - 500 055 Telangana. Annora Pharma Private Limited Survey No. 261, Annaram Village, Gummadidala Mandal Sangareddy, Telangana - 502313, India (IND). | No | 3-Fixed Dose Combination | Yes | For Pediatric patients at least weighing 40 kg or greater. | Store below 30°C (86°F). | 48/36/36/36/36/36 | Not Scored | Tentatively Approved 8/8/2018 | India | https://www.heteroworld.com/contact-us.php | 213 | Yes |
| 210963 | Tentatively Approved | Dolutegravir Tablets | 50 mg | Laurus Labs Limited | ANDA | Laurus Labs Limited | Laurus Labs Generic | 05/16/2019 | HDPE bottle packs of 30 with child-resistant closure and HDPE bottle packs of 90 with child-resistant closure. | Tentatively Approved | View Label | Dolutegravir | Tablets | Laurus Labs Limited, Plot No. 19, 20, and 21, Western Sector, APSEZ, Atchutapuram, Visakhapatnam -531011, Andhra Pradesh, India | No | Single | Yes | For Pediatric patients weighing at least 30 kg. | Store at 20°C to 25°C (68 to 77°F); excursions permitted between 15 to 30°C (59 to 86°F). | 36 | Not Scored | Tentatively Approved 5/16/2019 | India | http://www.lauruslabs.com/contact-us | 220 | Yes |
| 211148 | Tentatively Approved | Emtricitabine and Tenofovir Alafenamide Tablets | 200 mg/25 mg | Mylan Laboratories Limited | ANDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 01/02/2024 | HDPE bottles of 30’s and 90’s with desiccant | Tentatively Approved | View Label | Emtricitabine and Tenofovir Alafenamide | Tablets | Mylan Laboratories Limited (FDF-3), a Viatris Company Plot No. 11, 12 & 13, Indore Special Economic Zone Pharma Zone, Phase - II, Sector - III, Pithampur, District Dhar, Madhya Pradesh, India, 454775 | No | 2-Fixed Dose Combination | Yes | For pediatric patients weighing at least 14 kg and less than 35 kg - in combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor; For pediatric patients weighing at least 35 kg - all other indications. | Store below 30°C (86°F). Keep container tightly closed. Dispense only in original container. | 24 | Not Scored | Tentatively Approved 1/02/2024 | India | https://www.mylan.com/en/contact-mylan | 255 | Yes |
| 211868 | Tentatively Approved | Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets | 50 mg/300 mg/300 mg | Emcure Pharmaceuticals Limited | NDA | Emcure Pharmaceuticals Limited | Milan Laboratories (India) Private Limited | 07/12/2023 | HDPE bottles containing 30, 90 and 180 tablets with desiccant and child-resistant cap | Tentatively Approved | View Label | Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate | Tablets | Milan Laboratories (India) Private Limited Plot No. Z-96/A, Dahej, SEZ Phase– 2, Bharuch, Gujarat, India, 392130 - India | No | 3-Fixed Dose Combination | Yes | For pediatric patients weighing at least 35 kg | Store below 30°C (86°F). Store in original bottle. Protect from moisture and keep bottle tightly closed. Do not remove desiccant. | 24 | Not Scored | Tentative Approval 7/12/23 | India | https://www.emcure.com/contact-us/ | 246 | Yes |
| 211912 | Tentatively Approved | Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets | 50 mg/300 mg/300 mg | Celltrion Inc. | NDA | Aizant Drug Research Solutions Pct. Ltd. and Celltrion Pharm, Inc. | Celltrion Inc. | 04/13/2020 | HDPE Bottles of 30, 90, and 180 Tablets with desiccant, induction seal, and child-resistant cap. | Tentatively Approved | View Label | Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate | Tablets | Aizant Drug Research Solutions Pvt. Ltd. Survey No 172/173, Apparel Park Road, Dulapally Village, Dundigal- Gandimaisamma Mandal Medchal- Malkhajgiri , Hyderabad, Telangana, India, 500100 Celltrion Pharm, Inc. 82, 2 Sandan-ro, Ochang-eup, Cheongwon-gu , Cheongju-si, Chungcheongbuk-do, Korea, 28117 | No | 3-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 40 kg. | Store below 30°C (86°F). Store in original bottle, protect from moisture, and keep bottle tightly closed. Do not remove desiccant. | 42/42/39 | Not Scored | Tentatively Approved 4/13/2020 | South Korea and India | https://www.celltrion.com/en-us/contact/customer | 223 | Yes |
| 212114 | Approved | Emtricitabine and Tenofovir Disoproxil Fumarate Tablets | 200 mg/300 mg | Laurus Labs Limited | ANDA | Laurus Labs Limited | Laurus Generics Inc. | 07/26/2019 | HDPE Bottles of 30 and 90 tablets. | Approved | View Label | Emtricitabine and Tenofovir Disoproxil Fumarate | Tablets | Laurus Labs Limited, (VSP-2) (DRUG PRODUCT MANUFACTURER) Plot No. 19, 20 and 21, Western Sector, APSEZ, Atchutapuram Visakhapatnam, Andhra Pradesh, India 531011 | No | 2-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 35 kg. | Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). | 36 | Not Scored | Approved 7/26/2019 | India | http://www.lauruslabs.com/contact-us | 0 | Yes |
| 212179 | Tentatively Approved | Dolutegravir Tablets | 50 mg | Micro Labs Ltd | ANDA | Micro Labs Limited | Micro Labs USA Inc. | 09/13/2019 | HDPE bottles of 30, 60, and 90; with induction seal and child-resistant cap. | Tentatively Approved | View Label | Dolutegravir Sodium | Tablets | Micro Labs limited Plot No. S-155 to S-159 & N1, Phase III & Phase IV, Verna Industrial Estate, Verna, Goa, India 403722 | No | Single | Yes | For Pediatric patients weighing at least 40 kg. | Store at 25°C (77°F), excursions permitted between 15° to 30°C (59° to 86°F). | 24 | Not Scored | Tentatively Approved 9/13/2019 | India | http://www.microlabsltd.com/contact | 222 | No |
| 212303 | Tentatively Approved | Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets | 50 mg/300 mg/300 mg | Lupin Ltd. | NDA | Lupin Limited | Lupin Ltd. | 06/25/2021 | HDPE bottles of 30's, 60's, 90's and 180's with desiccant and child resistant closure. | Tentatively Approved | View Label | Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate | Tablets | Lupin Limited Unit-1, Plot No. 6A1, 6A2, Sector-17 Special Economic Zone, MIHAN, Motified Area Nagpur, Maharashtra, India - 441108 | No | 3-Fixed Dose Combination | Yes | For Pediatic patients weighing at least 35kg. | Store below 30°C (86°F). Store and dispense in original bottle, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant. Keep out of the reach of children. | 24 | Not Scored | Tentatively Approved 6/25/2021 | India | https://www.lupin.com/contact-us/ | 234 | Yes |
| 212427 | Tentatively Approved | Dolutegravir, Emtricitabine, and Tenofovir Alafenamide Tablets | 50 mg/200 mg/25 mg | Hetero Labs LTD Unit III | NDA | Hetero Labs LTD Unit III | Hetero Labs LTD Unit III | 01/18/2024 | HDPE bottles containing 30 or 100 tablets with desiccant and child-resistant closure | Tentatively Approved | View Label | Dolutegravir, Emtricitabine, and Tenofovir Alafenamide | Tablets | Hetero Labs Limited, Unit-III, Plot No. 22-110, Part-II, IDA Jeedimetla, Hyderabad Telangana – 500055, India | No | 3-Fixed Dose Combination | Yes | For pediatric patients weighing at least 25 kg. | Store below 30°C (86°F) and dispense in the original bottle and keep the bottle tightly closed to protect from moisture. Do not remove desiccant. Keep out of the reach of children. | 36 | Not Scored | Tentatively approved 01/18/2024 | India | https://www.heteroworld.com/contact-us.php | 256 | Yes |
| 212527 | Tentatively Approved | Dolutegravir, Lamivudine, and Tenofovir Alafenamide Tablets | 50 mg/300 mg/25 mg | Cipla Limited | NDA | Cipla Limited | Cipla Limited | 03/30/2022 | HDPE bottles containing 30 or 90 tablets with desiccant | Tentatively Approved | View Label | Dolutegravir, Lamivudine, and Tenofovir Alafenamide | Tablets | Cipla Limited - Patalganga Plot No. A – 42 ( Unit -II ), MIDC Patalganga, District Raigad, Patalganga, Patalganga, India 410220 | No | 3-Fixed Dose Combination | Yes | For pediatric patients weighing at least 25 kg | Store below 30°C (86°F). Store and dispense in original bottle, protect it from moisture, and keep bottle tightlyclosed. Do not remove desiccant bag/s. Keep out of the reach of children. | 24 | Not Scored | Tentative Approval 3/30/2022 | India | https://www.cipla.com/en/contact-us.html | 238 | Yes |
| 212579 | Approved | Atazanavir Capsules | 150 mg, 200 mg, 300 mg | Laurus Labs Limited | ANDA | Laurus Labs Limited | Laurus Generics Inc. | 04/30/2021 | HDPE bottle with child resistant closure of 60 and cartons of 60 unit doses in 60 unit dose blister packs (10X6) of the 150 mg and 200 mg strengths. HDPE bottle with child resistant closure of 30 and cartons of 30 unit doses in 30 unit dose blister pack | Approved | View Label | Atazanavir | Capsules | Plot No. 19, 20 and 21, Western Sector, APSEZ, Atchutapuram, Visakhapatnam Andhra Pradesh, India 531011 | No | Single | Yes | For pediatric patients at least 6 years of age and weighing at least 15 kg. | Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). | 36 | Not Scored | Approved 4/30/2021 | India | http://www.lauruslabs.com/contact-us | 235 | Yes |
| 212786 | Approved | Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets | 600 mg/300 mg/300 mg | Laurus Labs Limited | ANDA | Laurus Labs Limited | Laurus Generics Inc. | 05/14/2020 | HDPE Bottles of 30 or 90 Tablets with desiccant, induction seal, and child-resistant cap. | Approved | View Label | Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate | Tablets | Laurus Labs Limited, (VSP-2) Plot No. 19, 20 and 21, Western Sector, APSEZ, Atchutapuram Visakhapatnam, Andhra Pradesh, India 531011 | No | 3-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 40 kg. | Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). | 36 | Not Scored | Approved 5/14/2020 | India | http://www.lauruslabs.com/contact-us | 224 | Yes |
| 213038 | Approved | Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets | 400 mg/300 mg/300 mg | Laurus Labs Limited | ANDA | Laurus Labs Limited | Laurus Generics Inc. | 05/14/2020 | HDPE Bottles of 30, 90, or 180 Tablets with desiccant, induction seal, and child-resistant cap. | Approved | View Label | Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate | Tablets | Laurus Labs Limited, (VSP-2) Plot No. 19, 20 and 21, Western Sector, APSEZ, Atchutapuram Visakhapatnam, Andhra Pradesh, India 531011 | No | 3-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 35 kg. | Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). | 36 | Not Scored | Approved 5/14/2020 | India | http://www.lauruslabs.com/contact-us | 225 | Yes |
| 213509 | Tentatively Approved | Efavirenz, Emtricitabine, and Tenofovir Alafenamide Tablets | 400 mg/200 mg/25 mg | Mylan Pharmaceuticals Inc. | NDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 03/22/2024 | HDPE bottles containing 30 tablets with desiccant and non-child-resistant cap | Tentatively Approved | View Label | Efavirenz, Emtricitabine, and Tenofovir Alafenamide | Tablets | No | Single | No | Mylan Laboratories Limited (FDF-3), a Viatris Company Plot No. 11, 12 & 13, Indore Special Economic Zone Pharma Zone, Phase II Sector III, Pithampur, , District Dhar, Madhya Pradesh, India, 454775 | Store below 30°C (86°F). Store in the original bottle, protect from moisture, and keep bottle tightly closed. Do not remove desiccant. | 24 | Not Scored | Tentatively approved 3/22/2024 | India | https://www.mylan.com/en/contact-mylan | 257 | Yes | |
| 213541 | Approved | Emtricitabine and Tenofovir Disoproxil Fumarate Tablets | 600 mg/200 mg/300 mg | Laurus Labs Limited | ANDA | Laurus Labs Limited | Laurus Generics Inc. | 12/22/2021 | HDPE bottles of 30 and 90 tablets with child-resistance closures | Approved | View Label | Emtricitabine and Tenofovir Disoproxil Fumarate | Tablets | Laurus Labs Limited, (VSP-2) Plot No. 19, 20 and 21, Western Sector, APSEZ Atchutapuram, Visakhapatnam, Andhra Pradesh – 531011, India | No | 3-Fixed Dose Combination | Yes | For pediatric patients weighing at least 40 kg | Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). | 36 | Not Scored | Approved 12/22/2021 | India | http://www.lauruslabs.com/contact-us | 0 | Yes |
| 213556 | Tentatively Approved | Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets | 50 mg/300 mg/300 mg | Shanghai Desano Bio-Pharmaceuticals Co. Ltd. | NDA | Aizant Drug Research Solutions Pvt. Ltd. and Shanghai Desano Bio-Pharmaceutical Co. Ltd. | Shanghai Desano Bio-Pharmaceuticals Co. Ltd. | 10/06/2020 | HDPE Bottles of 30 or 90 tablets with desiccant and child-resistant closure. | Tentatively Approved | View Label | Dolutegravir, Lamivudine, Tenofovir Disoproxil Fumarate | Tablets | Aizant Drug Research Solutions Pvt Ltd Survey No 172/173, Apparel Park Road, Dulapally Village, Dundigal-Gandimaisamma Mandal,Medchal-Malkhajgiri District, Hyderabad Telangana, India 500100- Shanghai Desano Bio-Pharmaceutical Co. Ltd. 1479 Zhangheng Road, China (Shanghai) Pilot Free Trade Zone, Shanghai 201203, China | No | 3-Fixed Dose Combination | Yes | For pediatric patients weighing at least 35kg. | Store below 30°C (86°F). Store and dispense in original bottle, protect from moisture, and keep bottle tightly closed. Do not remove desiccant. Keep out of the reach of children. | 36 | Not Scored | Tentatively Approved 10/06/2020 | India and China | http://www.desano.com/en/contact.php | 228 | Yes |
| 213681 | Tentatively Approved | Dolutegravir, Emtricitabine, and Tenofovir Alafenamide Tablets | 50 mg/200 mg/25 mg | Laurus Labs Limited | NDA | Laurus Labs Limited | Laurus Generics Inc. | 10/12/2023 | Heavy weight HDPE bottles containing 30 and 90 tablets with desiccant and child-resistant cap | Tentatively Approved | View Label | Dolutegravir, Emtricitabine, and Tenofovir Alafenamide | Tablets | Laurus Labs Limited, (VSP-2) Plot No. 19, 20 and 21, Western Sector, APSEZ, Gurajapalem Village, Rambilli Mandal Anakapalli, Andhra Pradesh – 531011, India | No | 3-Fixed Dose Combination | Yes | For Pediatric patients weighing at least 25 kg. | Store below 30°C (86ºF). Store and dispense in the original bottle, protect it from moisture, and keep bottle tightly closed. Do not remove desiccant. | 36 | Not Scored | Tentatively Approved 10/12/23, TA'd 12/4/20 | India | http://www.lauruslabs.com/contact-us | 230 | Yes |
| 213696 | Tentatively Approved | Dolutegravir, Lamivudine, and Tenofovir Alafenamide Tablets | 50 mg/300 mg/25 mg | Laurus Labs Limited | NDA | Laurus Labs Limited | Laurus Generics Inc. | 01/25/2022 | HDPE bottles of 30 or 90 tablets with desiccant and child-resistant closure.HDPE bottles of 180 tablets with desiccant. | Tentatively Approved | View Label | Dolutegravir, Lamivudine, and Tenofovir Alafenamide | Tablets | Laurus Labs Limited, (VSP-2), Plot No. 19, 20 and 21, Western Sector APSEZ, Atchutapuram, Visakhapatnam Andhra Pradesh – 531011, India | No | 3-Fixed Dose Combination | Yes | For pediatric patients weighing at least 25 kg. | Store below 30°C (86°F). Store and dispense in original bottle, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant. Keep out of the reach of children. | 24 | Not Scored | Tentative Approved on 1/25/2022 | India | http://www.lauruslabs.com/contact-us | 236 | Yes |
| 213857 | Approved | Lopinavir and Ritonavir Tablets | 100/25mg & 200/50mg | Laurus Labs Limited | ANDA | Laurus Labs Limited | Laurus Generivs Inc. | 03/21/2022 | HDPE bottles of 60 tablets (for the 100mg/25mg) and 120 tablets (for the 200 mg/50 mg) | Approved | View Label | Lopinavir and Ritonavir | Tablets | Larus Labs Limited (VSP-2), Plot No. 19, 20 and 21, Western Sector, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh, India 531011 | No | 2-Fixed Dose Combination | Yes | For pediatric patients at least 6 months old | Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) | 36 | Not Scored | Approved 3/21/2022 | India | http://www.lauruslabs.com/contact-us | 237 | Yes |
| 213989 | Tentatively Approved | Emtricitabine and Tenofovir Alafenamide Tablets | 200 mg/25 mg | Laurus Labs Limited | ANDA | Laurus Labs Limited | Laurus Generics Inc. | 10/11/2023 | HDPE bottles containing 30 or 90 tablets with desiccant and child-resistant closure | Tentatively Approved | View Label | Emtricitabine and Tenofovir Alafenamide | Tablets | Laurus Labs Limited, (VSP-2) Plot No. 19, 20 and 21, Western Sector, APSEZ, Atchutapuram Visakhapatnam, Andhra Pradesh India, 531011 | No | 2-Fixed Dose Combination | Yes | For pediatric patients weighing at least 35 kg. | Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Keep container tightly closed. Dispense only in original container. | 24 | Not Scored | Tentatively Approved 10/11/2023 | India | https://lauruslabs.com/contact.html | 0 | Yes |
| 214183 | Tentatively Approved | Dolutegravir Tablets | 50 mg | Shanghai Desano Bio-Pharmaceutical Co., Ltd | ANDA | Shanghai Desano Bio-Pharmaceutical Co., Ltd | Shanghai Desano Bio-Pharmaceutical Co., Ltd | 09/13/2023 | HDPE bottles containing 30 tablets with a child-resistant closure | Tentatively Approved | View Label | Dolutegravir | Tablets | Shanghai Desano Bio-Pharmaceutical Co., Ltd. 1479 Zhangheng Road Zhangjiang High-tech Park Shanghai 201203, P.R.China | No | Single | Yes | For pediatric patients weighing at least 14 kg. | Store Dolutegravir tablets at 25°C (77°F); excursions permitted 15° to 30°C (59° to 86°F) | 24 | Not Scored | Tentatively Approved 9/13/2023 | China | http://www.desano.com/en/contact.php | 251 | No |
| 214397 | Tentatively Approved | Dolutegravir Sodium Tablets | 10mg, 25mg, 50mg | Macleods Pharmaceuticals Ltd. | ANDA | Macleods Pharmaceuticals Ltd. | Macleods Pharma USA, Inc. | 03/22/2021 | HDPE bottles of 30's, 90's and 180's with a non-child resistant closure. | Tentatively Approved | View Label | Dolutegravir | Tablets | Macleods Pharmaceuticals limited Plot No. 25-27, Survey No. 366, Premier Industrial Estate, Kachigam Daman, PIN-396210 India | No | Single | Yes | For Pediatric patients at least 4 weeks of age and weighing at least 3kg. | Store at 25°C (77°F); with excursions permitted between 15° to 30°C (59° to 86°F). | 24 | Not Scored | Tentatively Approved 3/22/2021 | India | http://www.macleodspharma.com/UnitedStates.asp | 233 | Yes |
| 214521 | Tentatively Approved | Dolutegravir Tablets for Oral Suspension | 10 mg | Mylan Laboratories Limited | NDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 11/19/2020 | HDPE Bottles of 30, 60, or 90 tablets with desiccant and non-child-resistant cap. | Tentatively Approved | View Label | Dolutegravir | Tablets for Oral Suspension | Mylan Laboratories Limited (FDF-3) Plot No. 11, 12 and 13, Indore Special Economic Zone Pharma Zone, Phase-II, Sector-III, Pithampur District Dhar, Madhya Pradesh, India. 454775. | No | Single | Yes | For Pediatric patients at least 4 weeks of age and weighing at least 3kg. | Store below 30°C (86°F). | 24 | Scored | Tentatively Approved 11/19/2020 | India | https://www.mylan.com/en/contact-mylan | 229 | Yes |
| 214544 | Tentatively Approved | Dolutegravir, Emtricitabine, and Tenofovir Alafenamide Tablets | 50 mg/200 mg/25 mg | Lupin Limited | NDA | Lupin Limited | Lupin Limited | 01/19/2023 | HDPE bottles of 30, 60 and 90 tablets with desiccant and child-resistance closures. HDPE bottles of 1000 tablets with desiccant and non-child-resistance closure | Tentatively Approved | View Label | Dolutegravir, Emtricitabine, and Tenofovir Alafenamide | Tablets | Lupin Limited Unit-1, Plot No. 6A1, 6A2, Sector-17 Special Economic Zone, MIHAN Nagpur, Maharashtra, India - 441108 | No | 3-Fixed Dose Combination | Yes | For pediatric patients weighing at least 25 kg | Store below 30°C (86°F). Store and dispense in the original bottle, protect it from moisture, and keep bottle tightly closed. Do not remove desiccant. Keep out of the reach of children. | 36/36/36/6 | Not Scored | Tentative Approval 1/19/2023 | India | https://www.lupin.com/contact-us/ | 242 | Yes |
| 214566 | Tentatively Approved | Dolutegravir Tablets for Oral Suspension | 10 mg | Macleods Pharmaceuticals Ltd. | NDA | Macleods Pharmaceuticals Ltd. | Macleods Pharma USA, Inc. | 03/16/2021 | HDPE bottles of 90 and 180 tablets with child resistant caps with desiccant. HDPE bottles of 90 and 180 tablets with child resistant caps without desiccant. | Tentatively Approved | View Label | Dolutegravir | Tablets for Oral Suspension | Macleods Pharmaceuticals Limited Plot No. 25-27, Survey No. 366 Premier Industrial Estate Kachigam, Daman Daman – 396210, India Macleods Pharmaceuticals Limited Plot No. M-50 to M-54-A, SEZ Phase - II Pithampur, Tehsil-Patera Dhar Indore, Madhya Pradesh - 454774 India | No | Single | Yes | For Pediatric patients at least 4 weeks of age and weighing at least 3kg. | Store below 30°C (86°F). Store and dispense the 10 mg tablets in the original bottle, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant. Keep out of the reach of children. | 36/24 | Scored | Tentatively Approved 3/16/2021 | India | http://www.macleodspharma.com/UnitedStates.asp | 232 | Yes |
| 215187 | Tentatively Approved | Dolutegravir, Lamivudine, and Tenofovir Alafenamide Tablets | 50 mg/300 mg/25 mg | Lupin Limited | NDA | Lupin Limited | Lupin Limited | 07/18/2023 | HDPE bottles containing 30 or 90 tablets with desiccant and child-resistant cap | Tentatively Approved | View Label | Dolutegravir, Lamivudine and Tenofovir Alafenamide | Tablets | M/s. Lupin Limited (Drug Product Manufacturing Site) Unit-1, Plot 6A1, 6A2, Sector -17 Special Economic Zone, MIHAN, Nagpur, Maharashtra, India, 441108 | No | 3-Fixed Dose Combination | Yes | For pediatric patients weighing at least 25 kg. | Store below 30°C (86°F). Store and dispense in original bottle. Keep bottle tightly closed. Do not remove desiccant. | 24 | Not Scored | Tentative Approval 7/18/2023 | India | https://www.lupin.com/contact-us/ | 247 | Yes |
| 215319 | Tentatively Approved | Dolutegravir Oral Films | 5 mg, 10 mg | Laurus Labs Limited | NDA | Laurus Labs Limited | Laurus Generics Inc. | 04/28/2023 | Cartons of 30 and 90 films individually packaged in either triple laminated tear off pouches or peel off pouches. | Tentatively Approved | View Label | Dolutegravir | Oral Films | "Laurus Labs Limited, (VSP-2) Plot No. 19, 20 and 21, Western Sector, APSEZ Gurajapalem Village, Rambilli Mandal Anakapalli, Andhra Pradesh – 531011, India | No | Single | Yes | For pediatric patients aged at least 4 weeks and weighing at least 3 kg. | Store below 30°C (86°F). Keep product in foil pouch until ready to use. Use right away after opening foil pouch. Keep out of the reach of children. | 18 | Not Scored | Tentatively Approved 4/28/2023 | India | http://www.lauruslabs.com/contact-us | 243 | Yes |
| 215448 | Tentatively Approved | Dolutegravir, Emtricitabine, and Tenofovir Alafenamide Tablets | 50 mg/200 mg/25 mg | Aurobindo Pharma Limited | NDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 05/26/2023 | HDPE bottles containing 30 or 90 tablets with dessicant and child-resistant closure | Tentatively Approved | View Label | Dolutegravir, Emtricitabine and Tenofovir Alafenamide | Tablets | APL Healthcare Limited, Unit IV Plot No. 16, APIIC M.P. SEZ, Menakuru Village Naidupeta mandal, Tirupati, Andhra Pradesh -524421, India | No | 3-Fixed Dose Combination | Yes | For pediatric patients weighing at least 25 kg | Store below 30°C (86°F). | 24 | Not Scored | Tentative Approval 5/26/23 | India | https://www.aurobindousa.com/contact/ | 245 | Yes |
| 216223 | Tentatively Approved | Abacavir, Dolutegravir, and Lamivudine Tablets | 600 mg/50 mg/300 mg | Laurus Labs Limited | ANDA | Laurus Labs Limited | Laurus Generics Inc. | 08/11/2022 | HDPE bottles of 30 and 90 tablets with desiccant and child-resistance closures | Tentatively Approved | View Label | Abacavir, Dolutegravir, and Lamivudine | Tablets | Laurus Labs Limited, (VSP-2) Plot No. 19, 20 and 21, Western Sector, APSEZ Atchutapuram, Visakhapatnam, Andhra Pradesh – 531011, India | No | 3-Fixed Dose Combination | Yes | For pediatric patients weighing at least 25 kg | Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). Store and dispense in the original package, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant. | 24 | Not Scored | Tentative Approval 8/11/2022 | India | http://www.lauruslabs.com/contact-us | 240 | Yes |
| 216332 | Approved | Abacavir and Lamivudine Tablets | 600 mg/300 mg | Laurus Labs Ltd. | ANDA | Laurus Labs Limited | Laurus Generics Inc. | 07/25/2022 | HDPE bottle packs of 30, 90, and 180 counts with child resistant closure. | Approved | View Label | Abacavir and Lamivudine | Tablets | Laurus Labs Limited, (VSP-2) Plot No. 19, 20 and 21, Western Sector, APSEZ, Atchutapuram Visakhapatnam, Andhra Pradesh India 531011 | No | 2-Fixed Dose Combination | Yes | For pediatric patients weighing at least 25 kg. | Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F) | 24 | Not Scored | Approved on 07/25/2022 | India | http://www.Lauruslabs.com/contact-us | 239 | Yes |
| 216731 | Tentatively Approved | Dolutegravir Tablets | 50 mg | Strides Pharma Global PTE Ltd | ANDA | Strides Pharma Science Limited | Strides Pharma Inc. | 09/12/2023 | HDPE bottles containing 28, 56, and 84 tablets with child-resistant closure | Tentatively Approved | View Label | Dolutegravir | Tablets | Strides Pharma Science Limited No 36/7, Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bengaluru, Karnataka, India. 562106 | No | Single | Yes | For Pediatric patients weighing at least 14 kg. | Store at 25°C (77°F); excursions permitted 15° to 30°C (59° to 86°F). | 24 | Not Scored | Tentative Approval 9/12/2023 | India | http://www.strides.com/contact.aspx | 250 | Yes |
| 216875 | Tentatively Approved | Emtricitabine and Tenofovir Alafenamide Tablets | 200 mg/25 mg | Aurobindo Pharma Limited | ANDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 12/19/2022 | HDPE bottles of 30 and 90 tablets with desiccant and child-resistance closures | Tentatively Approved | View Label | Emtricitabine and Tenofovir Alafenamide | Tablets | APL Healthcare Limited Unit-IV Plot No.16, APIIC, M.P. SEZ, Menakuru Village, Naidupeta Mandal, Tirupati District Andhra Pradesh, 524421 - India | No | 2-Fixed Dose Combination | Yes | For pediatric patients weighing at least 35 kg | Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). Keep Bottle tightly closed. Dispense only in original container. | 24 | Not Scored | Tentative Approval 12/19/2022 | India | http://www.aurobindousa.com/contact-us/ | 241 | Yes |
| 217016 | Tentatively Approved | Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets | 50 mg/300 mg/300 mg | Strides Pharma Global PTE Ltd | NDA | Strides Pharma Science Limited | Strides Pharma Inc. | 09/14/2023 | HDPE bottles containing 28, 30, 56, 60, 84 or 90 tablets with desiccant and child-resistant cap | Tentatively Approved | View Label | Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate | Tablet | Strides Pharma Science Limited No. 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bengaluru, Karnataka– 562106, India | No | 3-Fixed Dose Combination | Yes | For pediatric patients weighing at least 35 kg. | Store below 30°C (86°F). Store and dispense in original bottle, protect from moisture, and keep bottle tightly closed. Do not remove desiccant. Keep out of the reach of children. | 24 | Not Scored | Tentatively Approved 3/14/2023 | India | http://www.strides.com/contact.aspx | 252 | Yes |
| 217070 | Tentatively Approved | Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension | 60 mg/5 mg/30 mg | Aurobindo Pharma Limited | NDA | Aurobindo Pharma Limited | Aurobindo Pharma USA, Inc. | 08/14/2023 | HDPE bottles containing 90 or 180 tablets with desiccant and child-resistant cap | Tentatively Approved | View Label | Abacavir, Dolutegravir and Lamivudine | Tablets for Oral Suspension | APL Healthcare Limited Unit-IV Plot No.16, APIIC, M.P. SEZ, Menakuru Village, Naidupeta Mandal, Tirupati District Andhra Pradesh, 524421 - India | No | 3-Fixed Dose Combination | Yes | For pediatric patients aged at least 3 months and weighing at least 6 kg to less than 25 kg. | Store below 30°C (86°F). Store and dispense in original bottle, protect from moisture, and keep bottle tightly closed. Do not remove desiccant. | 24 | Not Scored | Tentatively Approved 8/14/2023 | India | http://www.aurobindousa.com/contact-us/ | 248 | Yes |
| 218193 | Tentatively Approved | Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension | 60 mg/5 mg/30 mg | Mylan Laboratories Limited | NDA | Mylan Laboratories Limited | Mylan Laboratories Limited | 08/16/2023 | HDPE bottles containing 60, 90, 120 or 180 tablets with desiccant and child-resistant cap | Tentatively Approved | View Label | Abacavir, Dolutegravir and Lamivudine | Tablets for Oral Suspension | Mylan Laboratories Limited (FDF-3) Plot No. 11, 12 & 13 Indore Special Economic Zone Pharma Zone, Phase II Sector III, Pithampur, District Dhar - 454775, Madhya Pradesh, India | No | 3-Fixed Dose Combination | Yes | For pediatric patients aged at least 3 months and weighing at least 6 kg to less than 25 kg. | Store below 30°C (86°F). Store and dispense in original bottle, protect from moisture, and keep bottle tightly closed. Do not remove desiccant. | 24 | Not Scored | Tentatively Approved 8/16/2023 | India | https://www.mylan.com/en/contact-mylan | 249 | Yes |
About the PEPFAR Database | FAQ | Contact Us
* The antiretroviral drugs listed in this database with an asterisk (*) in the FDA Original Action Sequence for PEPFAR were not submitted for FDA review under the PEPFAR program. FDA has determined that these applications satisfy the criteria for inclusion in the PEPFAR database.
Note: The Abbreviated New Drug Application (ANDA) Prescribing
Information (PI) is based on the New Drug Application (NDA) Reference Listed
Drug (RLD) for that drug product. It is the ANDA holder's responsibility to
monitor the PI for the NDA RLD and update their PI accordingly. Please be aware
a difference in the PI may exist depending on when the updated PI for the ANDA
is submitted and approved. We refer you to
Drugs@FDA
for approved NDA RLD PIs.
FDA will continually update and improve this interactive database and looks forward to hearing from stakeholders. Questions or comments about the PEPFAR database should be directed to
druginfo@fda.hhs.gov.