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President's Emergency Plan for AIDS Relief (PEPFAR) Database

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021837 Withdrawn Lamivudine, Stavudine, and Nevirapine Tablets 150 mg/40 mg/200 mg Strides Pharma Global PTE Limited. NDA Withdrawn Tablets No 3-Fixed Dose Combination Yes Not Scored Withdrawn 10/21/2020 Tentatively Approved 3/20/2008 http://www.strides.com/contact.aspx 64 No
021838 Withdrawn Stavudine and Lamivudine Tablets 40 mg/150 mg Strides Pharma Global PTE Limited. NDA Withdrawn Stavudine and Lamivudine Tablets No 2-Fixed Dose Combination Yes Not Scored Withdrawn 10/21/2020 Tentatively Approved 3/13/2007 http://www.strides.com/contact.aspx 38 No
021841 Withdrawn Lamivudine / Zidovudine Tablets Co-packaged with Nevirapine Tablets 150 mg/300 mg + 200 mg Pharmacare Limited NDA Withdrawn Lamivudine / Zidovudine Co-packaged with Nevirapine Tablets No 4-Fixed Dose Combination Yes Not Scored Withdrawn 1/19/2017 Tentatively Approved 1/24/2005 http://www.pharmacarelimited.com/contactus 2 No
021854 Withdrawn Stavudine / Lamivudine Tablets Co-packaged with Nevirapine Tablets 40 mg/150 mg + 200 mg Strides Pharma Global PTE Limited. NDA Withdrawn Stavudine / Lamivudine Co-packaged with Nevirapine Tablets Yes 4-Fixed Dose Combination Yes Not Scored Withdrawn 10/21/2020 Tentatively Approved 3/13/2007 http://www.strides.com/contact.aspx 39 No
021939 Withdrawn Lamivudine, Zidovudine, and Nevirapine Tablets 150 mg/300 mg/200 mg Aurobindo Pharma Limited NDA Withdrawn Lamivudine, Zidovudine, and Nevirapine Tablets No 3-Fixed Dose Combination Yes Not Scored Withdrawn 8/25/2023 Tentatively Approved 6/30/2006 https://www.aurobindousa.com/contact/ 24 No
021943 Withdrawn Lamivudine / Zidovudine Tablets Co-packaged with Efavirenz Tablets 150 mg/300 mg + 600 mg Aurobindo Pharma Limited NDA Withdrawn Lamivudine / Zidovudine Co-packaged with Efavirenz Tablets Yes 4-Fixed Dose Combination Yes Not Scored Withdrawn 8/30/2023 Tentatively Approved 3/06/2006 https://www.aurobindousa.com/contact/ 16 No
021944 Withdrawn Lamivudine / Zidovudine Tablets Co-packaged with Abacavir Tablets 150 mg/300mg + 300 mg Aurobindo Pharma Limited NDA Withdrawn Lamivudine / Zidovudine Co-packaged with Abacavir Tablets Yes 4-Fixed Dose Combination Yes Not Scored Withdrawn 8/25/2023 Tentatively Approved 7/26/2006 https://www.aurobindousa.com/contact/ 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/contact-us 33 No
021971 Withdrawn Lamivudine, Zidovudine, and Nevirapine Tablets 150 mg/300 mg/200 mg Cipla Limited NDA Withdrawn Lamivudine, Zidovudine, and Nevirapine Tablets No 3-Fixed Dose Combination Yes Not Scored Withdrawn 11/15/2021 Tentatively Approved 1/31/2007 https://www.cipla.com/contact-us 36 No
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/contact-us 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/contact-us 35 No
021988 Withdrawn Lamivudine / Zidovudine Tablets Co-packaged with Nevirapine Tablets 150 mg/300 mg + 200 mg Strides Pharma Global PTE Limited. NDA Withdrawn Lamivudine / Zidovudine Co-packaged with Nevirapine Tablets Yes 4-Fixed Dose Combination Yes Not Scored Withdrawn 10/21/2020 Tentatively Approved 3/02/2007 http://www.strides.com/contact.aspx 37 No
022018 Withdrawn Lamivudine and Zidovudine Tablets 150 mg/300 mg Pharmacare Limited NDA Withdrawn Lamivudine and Zidovudine Tablets No 2-Fixed Dose Combination Yes 24 Not Scored Withdrawn 11/09/2020 Approved 3/17/2018 Tentatively Approved 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 Withdrawn Stavudine / Lamivudine Tablets Co-packaged with Efavirenz Tablets 40 mg/150 mg + 600 mg Strides Pharma Global PTE Limited. NDA Withdrawn Stavudine / Lamivudine Co-packaged with Efavirenz Tablets Yes 4-Fixed Dose Combination Yes Not Scored Withdrawn 10/21/2020 Tentatively Approved 6/01/2007 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/contact-us 70 No
022177 Withdrawn Lamivudine, Stavudine, and Nevirapine Tablets 150 mg/30 mg/200 mg Strides Pharma Global PTE Limited. NDA Withdrawn Lamivudine, Stavudine, and Nevirapine Tablets No 3-Fixed Dose Combination Yes Not Scored Withdrawn 10/21/2020 Tentatively Approved 3/20/2008 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/ 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/ 97 No
022295 Withdrawn Abacavir Sulfate and Lamivudine Tablets 60 mg/30 mg Aurobindo Pharma Limited NDA Withdrawn Abacavir Sulfate and Lamivudine Tablets No 2-Fixed Dose Combination Yes Not Scored Withdrawn 8/25/2023 Tentatively Approved 12/12/2008 https://www.aurobindousa.com/contact/ 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/ 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/ 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/ 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/ 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/ 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.hetero.com/contact-us 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.hetero.com/contact-us 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.hetero.com/contact-us 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 https://www.macleodspharma.com/contact-us/ 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 https://www.macleodspharma.com/contact-us/ 114 No
022547 Withdrawn Abacavir Sulfate Tablets for Oral Suspension Dispersible tablets 60 mg Cipla Limited NDA Withdrawn Abacavir Sulfate Tablets for Oral Suspension No Single Yes Not Scored Withdrawn 4/29/2024 Tentatively Approved 3/04/2011 https://www.cipla.com/contact-us 128 No
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 https://www.aurobindousa.com/contact/ 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 https://www.aurobindousa.com/contact/ 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/ 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/contact-us 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 https://www.aurobindousa.com/contact/ 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 https://www.aurobindousa.com/contact/ 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 https://www.aurobindousa.com/contact/ 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 https://www.aurobindousa.com/contact/ 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 https://www.aurobindousa.com/contact/ 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 https://www.aurobindousa.com/contact/ 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 https://www.aurobindousa.com/contact/ 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/contact-us 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/ 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/contact-us 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/contact-us 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/contact-us 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/contact-us 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/ 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/ 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/contact-us 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 100Cartons 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 https://www.aurobindousa.com/contact/ 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/contact-us 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/contact-us 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.hetero.com/contact-us 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/contact-us 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.hetero.com/contact-us 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.hetero.com/contact-us 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.hetero.com/contact-us 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.hetero.com/contact-us 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.hetero.com/contact-us 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/ 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/contact-us 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/ 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 https://www.macleodspharma.com/contact-us/ 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/contact-us 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/ 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/ 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/contact-us 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.hetero.com/contact-us 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/ 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 https://www.macleodspharma.com/contact-us/ 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 https://www.macleodspharma.com/contact-us/ 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 Approved 04/02/2021; TA'd 2/26/2014 India https://www.cipla.com/contact-us 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/contact-us 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/contact-us 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/contact-us 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.hetero.com/contact-us 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.hetero.com/contact-us 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 https://www.macleodspharma.com/contact-us/ 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/contact-us 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.hetero.com/contact-us 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 https://www.microlabsusa.com/contact-us/ 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/contact-us 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.hetero.com/contact-us 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/contact-us 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.hetero.com/contact-us 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/contact-us 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 https://www.microlabsusa.com/contact-us/ 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.hetero.com/contact-us 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/contact-us 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 https://www.microlabsusa.com/contact-us/ 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 https://www.macleodspharma.com/contact-us/ 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/contact-us 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/ 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.hetero.com/contact-us 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/contact-us 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 https://www.microlabsusa.com/contact-us/ 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 Macleods Pharmaceuticals Limited Plot No. M-50 to M-54-A, SEZ Phase - II Pithampur, Tehsil-Patera Dhar, Madhya Pradesh - 454774 India No Single Yes For Pediatric patients at least 2 years of age and weighing at least 10 kg. Store below 30°C (86° F). 36 Not Scored Approved 1/26/2018 Tentatively Approved 8/5/2014 India https://www.macleodspharma.com/contact-us/ 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 https://www.macleodspharma.com/contact-us/ 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 https://www.macleodspharma.com/contact-us/ 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/contact-us 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 11/8/2012 India https://www.hetero.com/contact-us 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 https://www.macleodspharma.com/contact-us/ 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 https://www.microlabsusa.com/contact-us/ 216 No
204505 Withdrawn Lamivudine and Tenofovir Disoproxil Fumarate Tablets Co-packaged with Nevirapine Tablets 300 mg/300 mg + 200 mg Aurobindo Pharma Limited NDA Withdrawn Lamivudine/Tenofovir Disoproxil Fumarate + Nevirapine Tablets Yes 3-Fixed Dose Combination Yes Not Scored Withdrawn 8/25/2023 Tentatively Approved 10/18/2013 https://www.aurobindousa.com/contact/ 163 No
204568 Withdrawn Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets 600 mg/300 mg/300 mg Cipla LTD NDA Withdrawn Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablet No 3-Fixed Dose Combination Yes Not Scored Withdrawn 4/29/2024 Tentatively Approved 12/30/2013 https://www.cipla.com/contact-us 165 No
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. 07/25/2024 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 (86 to 77°F); excursions permitted to 15-30°C (59 to 86°F). Dispense in original container or USP equivalent tight container. 24 Not Scored Fully approved on 7/25/2024 Tentatively Approved 3/7/2016 India https://www.macleodspharma.com/contact-us/ 189 Yes
204806 Approved NA 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/ 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/contact-us 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 NA 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.hetero.com/contact-us 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 https://www.microlabsusa.com/contact-us/ 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.hetero.com/contact-us 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/contact-us 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 https://www.microlabsusa.com/contact-us/ 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 https://www.microlabsusa.com/contact-us/ 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 https://www.macleodspharma.com/contact-us/ 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/contact-us 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 https://www.microlabsusa.com/contact-us/ 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/contact-us 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/contact-us 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.hetero.com/contact-us 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.hetero.com/contact-us 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/contact-us 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/ 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 https://www.microlabsusa.com/contact-us/ 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/contact-us 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.hetero.com/contact-us 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/ 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/contact-us 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 https://www.microlabsusa.com/contact-us/ 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/contact-us 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 https://www.aurobindousa.com/contact/ 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 https://www.macleodspharma.com/contact-us/ 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 https://www.lauruslabs.com/contact-us.html 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 OXALIS LABS, Village Theda, P.O. Lodhimajra, Tehsil - Baddi, Solan, Himachal Pradesh 174101, India (IND) 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. 48/36/36 Not Scored Tentatively Approved 3/25/2019 India https://www.macleodspharma.com/contact-us/ 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.hetero.com/contact-us 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 https://www.lauruslabs.com/contact-us.html 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 Recommended dosage information for pediatric patients weighing at least 35 kg for HIV-1 PrEP, and at least 14 kg for treatment of HIV-1 infection, is available in the labeling.. 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/inquiry 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 https://www.microlabsusa.com/contact-us/ 222 No
212303 Tentatively Approved Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets 50 mg/300 mg/300 mg Lupin Ltd. NDA Lupin Limited Lupin Limited 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.hetero.com/contact-us 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/contact-us 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 https://www.lauruslabs.com/contact-us.html 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 https://www.lauruslabs.com/contact-us.html 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 https://www.lauruslabs.com/contact-us.html 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 https://www.lauruslabs.com/contact-us.html 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 https://www.lauruslabs.com/contact-us.html 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 https://www.lauruslabs.com/contact-us.html 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 https://www.lauruslabs.com/contact-us.html 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 Recommended dosage information for pediatric patients weighing at least 35 kg for HIV-1 PrEP, and at least 14 kg for treatment of HIV-1 infection, is available in the labeling. 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://www.lauruslabs.com/contact-us.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 https://www.macleodspharma.com/contact-us/ 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 https://www.macleodspharma.com/contact-us/ 232 Yes
215071 Tentatively Approved Emtricitabine and Tenofovir Alafenamide Tablets 200 mg/25 mg Lupin Limited ANDA Lupin Limited Lupin Limited 07/29/2024 HDPE bottles of 30’s and 60’s tablets with desiccant. Tentatively Approved View Label Emtricitabine and Tenofovir Alafenamide Tablets Lupin Limited Unit-1, Plot 6A1, 6A2, Sector -17, Special Economic Zone, MIHAN, Nagpur, Maharashtra, India, 441108 No 2-Fixed Dose Combination Yes Recommended dosage information for pediatric patients weighing at least 35 kg for HIV-1 PrEP, and at least 25 kg for treatment of HIV-1 infection, is available in the labeling. Store below 30°C (86° F). Keep bottle tightly closed. Dispense only in original container. 24 Not Scored Tentatively approved 7/29/2024 India https://www.lupin.com/contact-us/ 258 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 https://www.lauruslabs.com/contact-us.html 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 https://www.lauruslabs.com/contact-us.html 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 https://www.lauruslabs.com/contact-us.html 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 Recommended dosage information for pediatric patients weighing at least 35 kg for HIV-1 PrEP, and at least 25 kg for treatment of HIV-1 infection, is available in the labeling. 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 https://www.aurobindousa.com/contact/ 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 https://www.aurobindousa.com/contact/ 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.

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