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

Single and Combination Products
Single 2-Fixed Dose Combination 3-Fixed Dose Combination Co-Packaged
Single 2-Fixed Dose Combination 3-Fixed Dose combination Co-Packaged
112 59 42 13
Populations for Use
Pediatric Adult-Only
Pediatric Adult-Only
224 2
Application Status
Approved or Tentatively Approved ANDAs Withdrawn ANDAs Approved or Tentatively Approved NDAs Withdrawn NDAs
Approved or Tentatively Approved ANDAs Withdrawn ANDAs Approved or Tentatively Approved NDAs Withdrawn NDAs
116 17 70 23

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
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
021841 Withdrawn Lamivudine / Zidovudine Tablets Co-packaged with Nevirapine Tablets 150 mg/300 mg + 200 mg Pharmacare Limited NDA Withdrawn Lamivudine / Zidovudine Co-packaged with Nevirapine Tablets No Co-Packaged Yes Not Scored Withdrawn 1/19/2017 Tentatively Approved 1/24/2005 http://www.pharmacarelimited.com/contactus 2
077357 Withdrawn Lamivudine Tablets 150 mg Sun Pharmaceutical Industries Ltd. ANDA Withdrawn Lamivudine Tablets No Single Yes Not Scored Withdrawn 1/20/2016 Tentatively Approved 5/27/2005 https://www.sunpharma.com/contact/usa 3
077429 Withdrawn Nevirapine Tablets 200 mg Sun Pharmaceutical Industries Ltd. ANDA Withdrawn Nevirapine Tablets No Single Yes Not Scored Withdrawn 1/20/2016 Tentatively Approved 6/20/2005 https://www.sunpharma.com/contact/usa 4
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 6/20/2005 India http://www.aurobindousa.com/contact-us/ 6 Yes
077673 Approved Efavirenz Tablets 600 mg Aurobindo Pharma Limited ANDA Aurobindo Pharma Limited Aurobindo Pharma USA, Inc. 09/21/2018 HDPE bottle packs of 30 with child resistant closure and blister packs of 10 (3x 10's). Approved View Label Efavirenz Tablets Unit-III, Sy. No.313 & 314, Bachupally, Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, 500090, India Unit-VII, Sy.No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No.S1 (Part) SEZ (Pharma), TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, 509302 India No Single Yes For Pediatric patients at least 3 months of age and weighing at least 3.5kgs. Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F) 36 Not Scored Approved 9/21/2018 Tentatively Approved 6/24/2005 India http://www.aurobindousa.com/contact-us/ 7 Yes
077672 Approved Stavudine Capsules 15 mg, 20 mg, 30 mg, 40 mg Aurobindo Pharma Limited ANDA Aurobindo Pharma Limited Aurobindo Pharma USA, Inc. 12/29/2008 HDPE bottles of 60. Approved View Label Stavudine 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, 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 Indicated for all Pediatric patients. Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). Not Scored Approved 12/29/2008 Tentatively Approved 7/1/2005 India https://www.aurobindousa.com/contact-us/ 8 No
077558 Approved Lamivudine and Zidovudine Tablets 150 mg/300 mg Aurobindo Pharma Limited ANDA Aurobindo Pharma Limited Aurobindo Pharma USA, Inc. 05/05/2017 HDPE bottle of 60. Cartons of 60 unit doses in 10 unit dose blister packs (6X10). Approved View Label Lamivudine and Zidovudine Tablets Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090 Aurobindo Pharma Limited Unit-VII, Survey No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No.S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India. 509302. No 2-Fixed Dose Combination Yes For Pediatric patients weighing at least 30 kg and for whom a solid dosage form is appropriate. Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). Scored Approved 5/5/2017 Tentatively Approved 7/07/2005 India http://www.aurobindousa.com/contact-us/ 9 No
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
077267 Approved Zidovudine Tablets 300 mg Aurobindo Pharma Limited ANDA Aurobindo Pharma Limited Aurobindo Pharma USA, Inc. 09/19/2005 HDPE bottle of 60. Blister packs of 60 unit doses in packs of 10 (6X10). Approved View Label Zidovudine Tablets Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090. Aurobindo Pharma Limited Unit-VII, Survey No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No.S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India. 509302. No Single Yes For Pediatric patients at least 4 weeks of age and for whom a solid dosage form is appropriate. Store at 20 to 25°C (68 to 77°F). Not Scored Approved 9/19/2005 Tentatively Approved 8/25/2005 India http://www.aurobindousa.com/contact-us/ 11 No
077268 Approved Zidovudine Oral Solution 10 mg/mL Aurobindo Pharma Limited ANDA Aurobindo Pharma Limited Aurobindo Pharma USA, Inc. 09/19/2005 HDPE Bottles 240 mL Approved View Label Zidovudine Oral Solution Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090. No Single Yes For Pediatric patients at least 4 weeks of age. Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). 24 Not Scored Approved 9/19/2005 Tentatively Approved 09/07/2005 India http://www.aurobindousa.com/contact-us/ 12 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 Tentatively Approved 11/04/2005 India http://www.aurobindousa.com/contact-us/ 13 Yes
077774 Withdrawn Stavudine powder for Oral Solution 1 mg/mL Aurobindo Pharma Limited ANDA Withdrawn Stavudine Oral Solution No Single Yes Not Scored Withdrawn FR Effective 7/21/2017 Withdrawn 7/21/2014 Approved 12/29/2008 Tentatively Approved 12/21/2005 http://www.aurobindousa.com/contact-us/ 14
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) 24 Not Scored Approved 5/22/2012 Tentatively Approved 12/29/2005 India http://www.aurobindousa.com/contact-us/ 15 Yes
021943 Tentatively Approved Lamivudine / Zidovudine Tablets Co-packaged with Efavirenz Tablets 150 mg/300 mg + 600 mg Aurobindo Pharma Limited NDA Aurobindo Pharma Limited Aurobindo Pharma USA, Inc. 03/06/2006 Carton of 30 co-packages, consisting of 6 blister packs. Each blister card contains five copackages and each copackage contains 2 Lamivudine / Zidovudine tablets with 1 Efavirenz tablets 6x (5x3's). Tentatively Approved View Label Lamivudine / Zidovudine Co-packaged with Efavirenz Tablets Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090. Aurobindo Pharma Limited Unit-VII, Sy.No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No.S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India. 509302. Yes Co-Packaged Yes For Pediatric patients at least 12 years of age and weighing at least 40 kg. Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). 36 Not Scored Tentatively Approved 3/06/2006 India http://www.aurobindousa.com/contact-us/ 16 No
078128 Approved Zidovudine Capsules 100 mg Aurobindo Pharma Limited ANDA Aurobindo Pharma Limited Aurobindo Pharma USA, Inc. Lucid Pharma LLC 03/27/2006 HDPE bottle of 100 Cartons of 100 unit dose tablets in blister packs of 10 (10X10). Approved View Label Zidovudine Capsules Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090. Aurobindo Pharma Limited Unit-VII, Sy.No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No.S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India. 509302. No Single Yes For Pediatric patients at least 4 weeks of age and weighing at least 4 kg. Store at 20 to 25°C (68 to 77°F). Not Scored Approved 3/27/2006 India http://www.aurobindousa.com/contact-us/ 17 No
077844 Approved Abacavir Sulfate Tablets 300 mg Aurobindo Pharma Limited ANDA Aurobindo Pharma Limited Aurobindo Pharma USA, Inc. 12/17/2012 HDPE bottle of 60. Approved View Label Abacavir Sulfate Tablets Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090. Aurobindo Pharma Limited Unit-VII, Sy.No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No.S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India. 509302. No Single Yes For Pediatric patients at least 3 months of age, weighing at least 14 kg, and for whom a solid dosage form is appropriate. Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). 36 Scored Approved 12/17/2012 Tentatively Approved 5/17/2006 India http://www.aurobindousa.com/contact-us/ 18 Yes
077956 Approved Nevirapine Tablets 200 mg Cipla Limited ANDA Cipla Limited Cipla Limited 05/22/2012 HDPE bottle of 60 and 1000. Approved View Label Nevirapine Tablets Cipla Limited Goa Plot no. L-139 to L-146 (Unit III), L-147 to L-147-1 (Unit VII) and L-147/4 (Unit X) Verna Industrial Estate Verna, Goa, India. 403722. No Single Yes For Pediatric patients at least 15 days of age. Store at 20°C-25°C (68°F-77°F). 36 Scored Approved 5/22/2012 Tentatively Approved 5/19/2006 India https://www.cipla.com/en/contact-us.html 19
077916 Tentatively Approved Efavirenz Tablets 600 mg Cipla Limited ANDA Cipla Limited Cipla Limited 05/24/2006 HDPE bottles 30 and 500. Boxes of 60 unit dose tablets in blister packs of 10 (6X10). Tentatively Approved View Label Efavirenz Tablets Cipla limited, Goa Cipla Limited,L-139 to L-146, Verna Industrial Estate. Verna, Goa, India. 403722. Cipla Ltd., Goa Plot no. L-147 to L-147-1, Verna Industrial Estate, Verna Salcette. Verna, Goa, India. 403722. No Single Yes For Pediatric patients weighing at least 40 kg. Store at 20°C-25°C (68°F - 77°F). Not Scored Tentatively Approved 5/24/2006 India https://www.cipla.com/en/contact-us.html 20
077980 Tentatively Approved Lamivudine Oral Solution 10 mg/mL Cipla Limited ANDA Cipla Limited Cipla Limited 06/22/2006 HDPE bottles 100 mL and 240 mL. Tentatively Approved View Label Lamivudine Oral Solution Cipla limited Plot No. 9, 10, 15 (Unit I), Indore SEZ District Dhar, Madhya Pradesh, India. 454775. No Single Yes For Pediatric Patients at least 3 months of age. Store at 20°C - 25°C (68°F - 77°F); excursions permitted to 15°C - 30°C (59°F - 86°F). 18 Not Scored Tentatively Approved 6/22/2006 India https://www.cipla.com/en/contact-us.html 21
077950 Approved Abacavir Sulfate Oral Solution 20 mg/mL Aurobindo Pharma Limited ANDA Aurobindo Pharma Limited Aurobindo Pharma USA, Inc. Rising Pharmaceutical Inc. 03/14/2018 HDPE containers of 240 mL with child-resistant closure and tamper evident seal. Approved View Label Abacavir Sulfate Oral Solution Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090 No Single Yes For Pediatric patients at least 3 months of age. Store at 20 to 25°C (68 to 77°F). DO NOT FREEZE. May be refrigerated 24 Not Scored Approved 3/14/2018 Tentatively Approved 6/27/2006 India https://www.aurobindousa.com/contact-us/ 22 Yes
077672 Approved Stavudine Capsules 15 mg, 20 mg Aurobindo Pharma Limited ANDA Aurobindo Pharma Limited Aurobindo Pharma USA, Inc. 07/01/2005 HDPE bottles of 60. Approved View Label Stavudine Capsules Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090 No Single Yes Indicated for all Pediatric patients. 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 12/29/2008 Tentatively Approved 7/1/2005 India https://www.aurobindousa.com/contact-us/ 23 No
021939 Tentatively Approved Lamivudine, Zidovudine, and Nevirapine Tablets 150 mg/300 mg/200 mg Aurobindo Pharma Limited NDA Aurobindo Pharma Limited Aurobindo Pharma USA, Inc. 06/30/2006 HDPE bottle of 60. Carton of 60 unit dose tablets in blister packs (6x10). Tentatively Approved View Label Lamivudine, Zidovudine, and Nevirapine Tablets Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090 Aurobindo Pharma Limited Unit-VII, Sy.No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No.S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India. 509302. No 3-Fixed Dose Combination Yes For Pediatric patients at least 12 years of age and weighing at least 50 kg. Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). Not Scored Tentatively Approved 6/30/2006 India https://www.aurobindousa.com/contact-us/ 24 No
077275 Withdrawn Didanosine Tablets 100 mg, 150 mg, 200 mg Aurobindo Pharma Limited ANDA Withdrawn Didanosine Tablets /  Chewable /  Dispersible /  Buffered No Single Yes Not Scored Withdrawn FR Effective 7/21/2017 Withdrawn 7/21/2014 Approved 8/14/2012 Tentatively Approved 7/10/2006 https://www.aurobindousa.com/contact-us/ 25
021944 Tentatively Approved Lamivudine / Zidovudine Tablets Co-packaged with Abacavir Tablets 150 mg/300mg + 300 mg Aurobindo Pharma Limited NDA Aurobindo Pharma Limited Aurobindo Pharma USA, Inc. 07/26/2006 Carton containing 6 blister packs, each blister card contains five co-packages and each co-package contains two lamivudine/ zidovudine tablets and two abacavir tablets 6X(5X4) Tentatively Approved View Label Lamivudine / Zidovudine Co-packaged with Abacavir Tablets Aurobindo Pharma Limited Unit-III, Sy. No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090. Yes Co-Packaged Yes For Pediatric patients at least 12 years of age and weighing at least 40 kg. Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). 24 Scored Tentatively Approved 7/26/2006 India https://www.aurobindousa.com/contact-us/ 26 No
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
022018 Approved Lamivudine and Zidovudine Tablets 150 mg/300 mg Pharmacare Limited NDA Aspen Port Elizabeth (Pty) Ltd. Aspen Pharmacare 03/17/2018 HDPE bottles containing 60 tablets with desiccant, heat seal liner, and a child-resistant white polypropylene cap. Approved View Label Lamivudine and Zidovudine Tablets Aspen Port Elizabeth (Pty) Ltd. Corner Fairclough Road and Gibaud Road Korsten, Port Elizabeth, Eastern Cape Province, South Africa 6020. No 2-Fixed Dose Combination Yes For Pediatric patients weighing at least 30 kg. Store between 2°C and 30°C (36°F - 86°F). Protect from moisture and light. 24 Not Scored Approved 3/17/2018 Tentatively Approved 8/23/2006 South Africa http://www.pharmacarelimited.com/contactus 28 No
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
077411 Approved Lamivudine and Zidovudine Tablets 150 mg/300 mg Cipla Limited ANDA Cipla Limited Cipla Limited 09/07/2019 HDPE bottles of 30, 60, and 1000. Unit dose blister pack in boxes of 100 tablets (10X10). Approved View Label Lamivudine and Zidovudine Tablets Cipla Limited, L139 to L146 (Unit III and IV), L147 to L-147/1 (Unit VII). Verna Industrial Area, Verna, Salcette, Goa 403 722, India (IND) Cipla Limited, Plot No. A-42, Patalganga (Unit II) Industrial Area, Patalganga, Raigad, Maharashtra 410 220, India (IND) No 2-Fixed Dose Combination Yes For Pediatric patients weighing at least 30 kg. Store between 20 and 25°C (68 and 77°F). 24 Scored Approved 9/7/2018 Tentatively Approved 9/13/2006 India https://www.cipla.com/en/contact-us.html 30
078112 Withdrawn Didanosine Powder for Oral Solution 10 mg/mL Aurobindo Pharma Limited ANDA Withdrawn Didanosine Powder for Oral Solution No Single Yes Not Scored Withdrawn FR Effective 7/21/2017 Withdrawn 7/21/2014 Approved 3/8/2007 Tentatively Approved 10/5/2006 https://www.aurobindousa.com/contact-us/ 31
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 11/06/2006 India https://www.cipla.com/en/contact-us.html 32
021969 Withdrawn Stavudine, Lamivudine, and Nevirapine Tablets 150 mg/40 mg/200 mg, 150 mg/30 mg/200 mg Cipla Limited NDA Withdrawn Stavudine, Lamivudine, and Nevirapine Tablets No 3-Fixed Dose Combination Yes Not Scored Withdrawn 3/15/2016 Tentatively Approved 11/17/2006 https://www.cipla.com/en/contact-us.html 33
078064 Approved Efavirenz Capsules 50 mg, 100 mg, 200 mg Aurobindo Pharma Limited ANDA Aurobindo Pharma Limited Aurobindo Pharma USA, Inc. 12/15/2017 HDPE bottles of 30 and blister packs of 30 unit dose capsules (3X10) for all dosage strengths. HDPE bottles of 90 and blister packs of 90 unit dose tablets (9X10) of 200mg capsules. Approved View Label Efavirenz Capsules Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090. Aurobindo Pharma Limited Unit-VII, Sy.No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No.S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India. 509302. No Single Yes For Pediatric patients at least 3 months of age and weighing at least 3.5 kg. Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). 36 Not Scored Approved 12/15/2017 Tentatively Approved 12/19/2006 India https://www.aurobindousa.com/contact-us/ 34 No
021974 Withdrawn Stavudine and Lamivudine Tablets 150 mg/30 mg, 150mg/40 mg Cipla Limited NDA Withdrawn Stavudine and Lamivudine Tablets No 2-Fixed Dose Combination Yes Not Scored Withdrawn 3/11/2016 Tentatively Approved 1/19/2007 https://www.cipla.com/en/contact-us.html 35
021971 Tentatively Approved Lamivudine, Zidovudine, and Nevirapine Tablets 150 mg/300 mg/200 mg Cipla Limited NDA Cipla Limited Cipla Limited 01/31/2007 HDPE bottles of 30, 60 and 500. Tentatively Approved View Label Lamivudine, Zidovudine, and Nevirapine Tablets Cipla Limited -Goa Unit 3, Unit 4, Unit 7, Verna Industrial Area, Verna Salcette, Verna, Goa, India 403722 Cipla Limited -Indore Unit IV, Plot No. 9, 10 & 15, Indore Special Economic Zone, Phase II, Pithampur, District Dhar, Madhya Pradesh, India 454775 No 3-Fixed Dose Combination Yes For pediatric patients at least 12 years of age and weighing at least 50Kg Store at 15°C - 25°C (59°F - 77°F) 24 Not Scored Tentatively Approved 1/31/2007 India https://www.cipla.com/en/contact-us.html 36
021988 Tentatively Approved Lamivudine / Zidovudine Tablets Co-packaged with Nevirapine Tablets 150 mg/300 mg + 200 mg Strides Pharma Global PTE Limited. NDA Strides Pharma Science Limited Strides Pharma Global PTE Limited. 03/02/2007 Co-packaged in a carton contains two HDPE bottles of 60 tablets of Lamivudine/Zidovudine and Nevirapine respectively, with non child-resistant snap on cap and tamper evident strip (60 unit doses per carton). Tentatively Approved View Label Lamivudine / Zidovudine Co-packaged with Nevirapine Tablets Strides Pharma Science Limited No 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bengaluru, Karnataka, India. 562106 Yes Co-Packaged Yes For Pediatric patients weighing at least 30 kg. Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). 24 Scored Tentatively Approved 3/02/2007 India http://www.strides.com/contact.aspx 37 Yes
021838 Tentatively Approved Stavudine and Lamivudine Tablets 30 mg/150 mg Strides Pharma Global PTE Limited. NDA Strides Pharma Science Limited Strides Pharma Global PTE Limited. 03/13/2007 HDPE bottle of 60 tablets with non child-resistant snap on cap and tamper evident strip. Tentatively Approved View Label Stavudine and Lamivudine Tablets Strides Pharma Science Limited No 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bengaluru, Karnataka, India. 562106 No 2-Fixed Dose Combination Yes For Pediatric patients at least 12 years of age and weighing at least 60 kg. Store below 25°C. Protect from light. 24 Not Scored Tentatively Approved 3/13/2007 India http://www.strides.com/contact.aspx 38 No
021854 Tentatively Approved Stavudine / Lamivudine Tablets Co-packaged with Nevirapine Tablets 40 mg/150 mg + 200 mg Strides Pharma Global PTE Limited. NDA Strides Pharma Science Limited Strides Pharma Global PTE Limited. 03/13/2007 Co-packaged in a carton contains two HDPE bottles of 60 tablets of Stavudine/Lamivudine and Nevirapine respectively, with non child-resistant snap on cap and tamper evident strip (60 unit doses per carton). Tentatively Approved View Label Stavudine / Lamivudine Co-packaged with Nevirapine Tablets Strides Pharma Science Limited No 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bengaluru, Karnataka, India. 562106 Yes Co-Packaged Yes For pediatric patients older than 12 years of age and weighing at least 60 kg. Store below 30°C. Protect from light. Not Scored Tentatively Approved 3/13/2007 India http://www.strides.com/contact.aspx 39 No
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 Yes
078509 Tentatively 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. 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 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 Tentatively Approved 3/26/2007 India http://www.strides.com/contact.aspx 41 Yes
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
078349 Approved Zidovudine Capsules 100 mg Cipla Limited ANDA Cipla Limited Cipla Limited 05/23/2007 HDPE bottles of 100 and 1000. Approved View Label Zidovudine Capsules Cipla Limited Plot No L-147 to L-147 (Unit VII),Plot No L139-L146 (Unit IV),and L-147-4 (Unit X) Verna Industrial Estate, Verna, Goa, India. 403722. No Single Yes For Pediatric patients at least 4 weeks of age and weighing at least 4 kg. Store at 20°C-25°C (68°F-77°F). 24 Not Scored Approved 5/23/2007 India https://www.cipla.com/en/contact-us.html 44
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 Co-Packaged Yes For Pediatric patients at least 12 years of age and weighing at least 40 kg. Store at 20 to 25° C (68 to 77° F). 24 Not Scored Tentatively Approved 6/01/2007 India http://www.strides.com/contact.aspx 45 Yes
022097 Tentatively Approved Stavudine / Lamivudine Tablets Co-packaged with Efavirenz Tablets 40 mg/150 mg + 600 mg Strides Pharma Global PTE Limited. NDA Strides Pharma Science Limited Strides Pharma Global PTE Limited. 06/01/2007 HDPE bottles of 60 Stavudine/Lamivudine tablets and 30 Efavirenz tablets. Tentatively Approved View Label Stavudine / Lamivudine Co-packaged with Efavirenz Tablets Strides Pharma Science Limited No 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bengaluru, Karnataka, India. 562106 Yes Co-Packaged Yes For Pediatric patients at least 12 years of age and weighing at least 60 kg. Store at 20 to 25°C (68 to 77° F). 15 Not Scored Tentatively Approved 6/01/2007 India http://www.strides.com/contact.aspx 46 No
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 5/22/12 Tentatively Approved 7/10/2007 China http://www.prinstonpharm.com/col.jsp?id=164 47 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 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
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 Tentatively Approved 8/13/2007 India https://www.heteroworld.com/contact-us.php 50 Yes
021972 Withdrawn Stavudine, Lamivudine, and Nevirapine Tablets for Oral Suspension 30 mg/6 mg/50 mg, 60 mg/12 mg/100 mg Cipla Limited NDA Withdrawn Stavudine, Lamivudine, and Nevirapine Tablets for oral suspension No 3-Fixed Dose Combination Yes Not Scored Withdrawn 3/7/2017 Tentatively Approved 8/13/2007 https://www.cipla.com/en/contact-us.html 51
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
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 Tentatively Approved 10/29/2007 India https://www.cipla.com/en/contact-us.html 53
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
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
079071 Tentatively Approved Tenofovir Disoproxil Fumarate Tablets 300 mg Mylan Laboratories Limited ANDA Mylan Laboratories Limited Mylan Laboratories Limited 11/30/2007 HDPE bottles of 30 and 100. Cartons of 20 unit dose tablets in blister packs of 10 (2X10). Tentatively 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 17 kg. Store at 20 to 25°C (68 to 77°F). Not Scored Tentatively Approved 11/30/2007 India https://www.mylan.com/en/contact-mylan 56 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
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
078850 Tentatively Approved Lamivudine Tablets 150 mg, 300 mg Hetero Labs Limited Unit III ANDA Hetero Labs Limited Unit III Hetero Labs Limited Unit III 01/29/2008 HDPE bottle of 60 with child resistant closure of 150 mg strength. HDPE bottle of 30 with child resistant closure of 300 mg strength. HDPE bottles of 600 for both strengths. Tentatively Approved View Label Lamivudine Tablets Hetero Labs Limited Unit III Plot No. 22-110, Part-II, Industrial Development Area Jeedimetla, Hyderabad, Telangana, India 500055. No Single Yes For Pediatric patients at least 3 months of age and weighing at least 14 kg. Store lamivudine tablets at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). 24 Not Scored Tentatively Approved 1/29/2008 India https://www.heteroworld.com/contact-us.php 59 Yes
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
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
078957 Withdrawn Stavudine Capsules 15 mg, 20 mg, 30 mg, 40 mg Hetero Labs Limited Unit III ANDA Withdrawn Stavudine Capsules No Single Yes Not Scored Withdrawn FR Effective 4/8/2020 Withdrawn 11/1/2019 Approved 12/29/2008 Tentatively Approved 2/28/2008 https://www.heteroworld.com/contact-us.php 62
078886 Approved Efavirenz Tablets 600 mg Hetero Labs Limited Unit III ANDA Hetero Labs Limited Camber Pharmaceuticals, Inc. 04/27/2018 HDPE bottles of 30 and 250. Approved View Label Efavirenz Tablets Hetero Labs Limited Unit III Plot No. 22-110, Part-II, IDA Jeedimetla, Hyderabad, Telangana, India 500055. Hetero Labs Limited Unit-V SEZ Unit I TSIIC SEZ,, Polepally Village, Jadcherla Mandal, Mahaboob Nagar, Telangana, India 509301 No Single Yes For Pediatric patients at least 3 months of age and weighing at least 3.5 kg. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Not Scored Approved 4/27/2018 Tentatively Approved 2/29/2008 India https://www.heteroworld.com/contact-us.php 63 Yes
021837 Tentatively Approved Lamivudine, Stavudine, and Nevirapine Tablets 150 mg/40 mg/200 mg Strides Pharma Global PTE Limited. NDA Strides Pharma Science Limited Strides Acrolab Limited 03/20/2008 HDPE bottles of 60. Tentatively Approved View Label Lamivudine, Stavudine, and Nevirapine Tablets Strides Pharma Science Limited No 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bengaluru, Karnataka, India. 562106 No 3-Fixed Dose Combination Yes For Pediatric patients at least 12 years of age and weighing at least 50 kg. Store below 25°C. 24 Not Scored Tentatively Approved 3/20/2008 India http://www.strides.com/contact.aspx 64 No
022177 Tentatively Approved Lamivudine, Stavudine, and Nevirapine Tablets 150 mg/30 mg/200 mg Strides Pharma Global PTE Limited. NDA Strides Pharma Science Limited Strides Acrolab Limited 03/20/2008 HDPE bottles of 60. Tentatively Approved View Label Lamivudine, Stavudine, and Nevirapine Tablets Strides Pharma Science Limited No 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bengaluru, Karnataka, India. 562106 No 3-Fixed Dose Combination Yes For Pediatric patients at least 12 years of age and weighing at least 50 kg. Store below 25°C. 24 Not Scored Tentatively Approved 3/20/2008 India http://www.strides.com/contact.aspx 65 No
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 4/25/2008 India https://www.heteroworld.com/contact-us.php 66 Yes
090092 Approved Zidovudine Tablets 300 mg Hetero Labs Limited Unit III ANDA Hetero Labs Limited Unit III and Ascent Pharmaceuticals Camber Pharmaceuticals, Inc 04/25/2008 HDPE bottle of 60 and 600 tablets. Approved View Label Zidovudine Tablets Hetero Labs Limited Unit III Plot No. 22-110, Part-II, IDA Jeedimetla, Hyderabad, Telangana, India. 500055 Ascent Pharmaceuticals, Inc. 400 S Technology Dr Central Islip, New York, USA. 11722 No Single Yes For Pediatric patients at least 4 weeks of age and weighing at least 4 kg. Store at 20 to 25° C (68 to 77°F). 36 Not Scored Approved 4/25/2008 India https://www.heteroworld.com/contact-us.php 67 Yes
079188 Tentatively Approved Emtricitabine Capsules 200 mg Aurobindo Pharma Limited ANDA Aurobindo Pharma Limited Aurobindo Pharma USA, Inc. 05/09/2008 HDPE bottles 30 and 500. Tentatively 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 Tentatively Approved 5/09/2008. India https://www.aurobindousa.com/contact-us/ 68 No
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 Tentatively Approved 5/15/2008 India https://www.mylan.com/en/contact-mylan 69 Yes
022167 Withdrawn Lamivudine and Stavudine Tablets for Oral Suspension 60 mg/12 mg, 30 mg/6 mg Cipla Limited NDA Withdrawn Lamivudine and Stavudine Tablets for Oral Suspension No 2-Fixed Dose Combination Yes Not Scored Withdrawn 2/23/2017 Tentatively Approved 6/19/2008 https://www.cipla.com/en/contact-us.html 70
077981 Approved Zidovudine Oral Solution 50 mg/5 mL Cipla Limited ANDA Cipla Limited Cipla Limited 06/26/2008 HDPE bottle 240 mL. Approved View Label Zidovudine Oral solution Cipla limited L-139 to L-146, Verna Industrial Estate Verna, Salcette, Goa, India. 403722. Cipla Limited Unit I, Plot No.9, 10 & 15; Indore Special Economic Zone, Phase II, Pithampur, Madhya Pradesh, India. 454775. No Single Yes For Pediatric patients at least 6 weeks of age. Store at 20 to 25°C (68 to 77 °F). 24 Not Scored Approved 6/26/2008 India https://www.cipla.com/en/contact-us.html 71
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 Tentatively Approved 9/03/2008 India https://www.aurobindousa.com/contact-us/ 72 Yes
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
022293 Withdrawn Abacavir Sulfate Tablets 60 mg Aurobindo Pharma Limited NDA Withdrawn Abacavir Sulfate Tablets No Single Yes Not Scored Withdrawn 8/7/2013 Tentatively Approved 9/12/2008 https://www.aurobindousa.com/contact-us/ 74
090094 Approved Didanosine Delayed-Release Capsules 125 mg, 200 mg, 250 mg, 400 mg Aurobindo Pharma Limited ANDA Aurobindo Pharma Limited Aurobindo Pharma USA, Inc. 09/24/2008 HDPE bottles of 30 and 500 of all dosage strengths. Blister packs of 14 unit doses in cartons of 140 (10 x 14) of the 125 mg strength. Blister packs of 10 unit doses in cartons of 100 (10X10) of the 200 mg and 250 mg strength. Blister packs of 5 unit do Approved View Label Didanosine Delayed - release Capsules Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090 No Single Yes For Pediatric patients at least 6 years of age and weighing at least 20 kg. Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). 24 Not Scored Approved 9/24/2008 India https://www.aurobindousa.com/contact-us/ 75 No
090198 Approved Lamivudine Tablets 150 mg, 300 mg Macleods Pharmaceuticals Limited ANDA Macleods Pharmaceuticals Limited Macleods Pharma USA, Inc. 05/01/2019 HDPE bottle of 60 of the 150 mg tablets. HDPE bottle of 30 of the 300 mg tablets. Approved View Label Lamivudine Tablets Macleods Pharmaceuticals Limited Survey No 366, Premier Industrial Estate, Kachigam Plot No. 25 - 27 Daman, Daman, India.396210. No Single Yes For Pediatric patients at least 3 months of age and weighing at least 14 kg. Store lamivudine tablets at 20 to 25°C (68 to 77° F); excursions permitted to 15 to 30° C (59 to 86° F). 36 Not Scored Approved 5/1/2019 Tentatively Approved 10/7/2008 India http://www.macleodspharma.com/UnitedStates.asp 76 Yes
022061 Tentatively Approved Lamivudine, Nevirapine, and Zidovudine Tablets 150 mg/200 mg/300 mg Mylan Laboratories Limited NDA Mylan Laboratories Limited Granules 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 Gagillapur Village, Qutubullapur Mandal, Rangareddy District Hyderabad, Telangana India. 5000043 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
022297 Withdrawn Efavirenz Tablets 100 mg Aurobindo Pharma Limited NDA Withdrawn Efavirenz Tablets No Single Yes Not Scored Withdrawn 8/7/2013 Tentatively Approved 12/12/2008 https://www.aurobindousa.com/contact-us/ 78
022295 Tentatively Approved Abacavir Sulfate and Lamivudine Tablets 60 mg/30 mg Aurobindo Pharma Limited NDA Aurobindo Pharma Limited Aurobindo Pharma USA, Inc. 12/12/2008 HDPE bottles of 30 and 60. Blister packs of 10 unit doses in cartons of 100 (10X10). Tentatively Approved View Label Abacavir Sulfate and Lamivudine Tablets Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090 No 2-Fixed Dose Combination Yes For Pediatric patients at least 3 months of age. Store at 25 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 89°F). 24 Scored Tentatively Approved 19/12/2008 India https://www.aurobindousa.com/contact-us/ 79 Yes
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
090647 Approved Tenofovir Disoproxil Fumarate Tablets 150 mg, 200 mg, 250 mg, 300 mg Aurobindo Pharma Limited ANDA Aurobindo Pharma Limited Aurobindo Pharma USA, Inc. 01/26/2018 HDPE bottles of 30 of 150mg, 200mg, 250 mg, and 300 mg. Blister packs of 10 unit dose tablets in cartons of 3 (3X10) for 150 g, 200 mg, and 250 mg. Approved View Label Tenofovir Disoproxil Fumarate Tablets Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090 Aurobindo Pharma Limited Unit-VII, Sy.No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No.S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India. 509302. No Single Yes For Pediatric patients at least 2 years of age and weighing at least 17 kg. Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). 24 Not Scored Approved 1/26/2018 Tentatively Approved 2/18/2009 India https://www.aurobindousa.com/contact-us/ 81 Yes
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
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
090471 Tentatively Approved Lopinavir and Ritonavir Tablets 100 mg/25 mg, 200 mg/50 mg Aurobindo Pharma Limited ANDA Aurobindo Pharma Limited Aurobindo Pharma USA, Inc. 03/10/2009 HDPE bottle of 120 for 200 mg/50 mg strength. HDPE bottle of 60 for 100 mg/25 mg strength. Tentatively Approved View Label Lopinavir and Ritonavir Tablets Aurobindo Pharma Limited Unit-III, Sy. No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District, Medchal, Telangana, India. 500090. No 2-Fixed Dose Combination Yes For pediatric patients at least 6 months of age. Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). 36 Not Scored Tentatively Approved 3/10/09 India https://www.aurobindousa.com/contact-us/ 84 Yes
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
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
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
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
090513 Approved Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 mg/300 mg Aurobindo Pharma Limited ANDA Aurobindo Pharma Limited Aurobindo Pharma USA, Inc. 01/26/2018 HDPE bottle of 30 with child-resistant closure and desiccant Approved View Label Emtricitabine and Tenofovir Disoproxil Fumarate Tablets Aurobindo Pharma Limited Unit-III, Survey No.313 & 314, Bachupally Bachupally Mandal, Medchal-Malkajgiri District Medchal, Telangana, India. 500090 Aurobindo Pharma Limited Unit-VII, Sy.No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No.S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India. 509302. No 2-Fixed Dose Combination Yes For Pediatric patients weighing at least 17 kg. Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). 24 Not Scored Approved 1/26/2018 Tentatively Approved 3/30/2009 India https://www.aurobindousa.com/contact-us/ 89 Yes
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 Tentatively Approved 3/31/2009 India http://www.macleodspharma.com/UnitedStates.asp 90 Yes
078800 Approved Tenofovir Disoproxil Fumarate Tablets 300 mg Cipla Limited ANDA Cipla Limited Cipla USA, Inc. 01/26/2018 HDPE bottles of 30 with desiccant and child-resistant closure. HDPE bottles of 1000 with desiccant, sanicoil, and with non child-resistant closure. Approved View Label Tenofovir Disoproxil Fumarate Tablets Cipla Limited, Unit VII, L139 to L146,S-103toS-105,S-107toS-112,L147toL-147/1/2/3/4,L-138,L-150,S-116,M-61,62,63 Verna Industrial Estate, Verna, Salcette, Goa, India. 403722. No Single Yes For Pediatric patients at least 2 years of age, weighing at least 35 kg, and for whom a solid dosage form is appropriate. Store at 25°C (77°F), excursions permitted between 15 to 30°C (59 to 86°F). 24 Not Scored Approved 1/26/2018 Tentatively Approved 4/29/2009 India https://www.cipla.com/en/contact-us.html 91
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 Co-Packaged Yes For Pediatric patients weighing at least 30 kg. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). 24 Not Scored Tentatively Approved 5/07/2009 India https://www.heteroworld.com/contact-us.php 92 No
090679 Approved Lamivudine and Zidovudine Tablets 150 mg/300 mg Macleods Pharmaceuticals Limited ANDA Macleods Pharmaceuticals Limited Macleods Pharma USA, Inc. 08/29/2018 HDPE bottles of 60. Blister packs of 10 unit doses packed in 60's (6X10) and 120's (12X10). Approved View Label Lamivudine and Zidovudine Tablets Macleods Pharmaceuticals Limited Plot No. 25 – 27, Survey No. 366, Premier Industrial Estate, Kachigam, Daman – 396210, India. No 2-Fixed Dose Combination Yes For Pediatric patients weighing at least 30 kg. Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F). Scored Approved 8/29/2018 Tentatively Approved 5/29/2009 India http://www.macleodspharma.com/UnitedStates.asp 93 Yes
078545 Approved Lamivudine Tablets 300 mg Mylan Laboratories Limited ANDA Mylan Laboratories Limited Mylan Laboratories Limited 03/05/2019 HDPE bottles of 60. Cartons of 60 unit dose tablets in 10 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 at least 3 months of age and weighing at least 14 kg. Store at 20 to 25°C (68 to 77°F). 24 Not Scored Approved 3/5/2019 Tentatively Approved 6/22/2009 India https://www.mylan.com/en/contact-mylan 94 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
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
022294 Withdrawn Zidovudine Tablets 60 mg Aurobindo Pharma Limited NDA Withdrawn Zidovudine Tablets No Single Yes Not Scored Withdrawn FR Effective 7/21/2017 Withdrawn 8/7/2013 Approved 7/23/2009 https://www.aurobindousa.com/contact-us/ 97
022296 Withdrawn Lamivudine and Zidovudine Tablets 30 mg/60 mg Aurobindo Pharma Limited NDA Withdrawn Lamivudine and Zidovudine Tablets No 2-Fixed Dose Combination Yes Not Scored Withdrawn 7/12/2019 Tentatively Approved 7/23/2009 https://www.aurobindousa.com/contact-us/ 98
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 desiccant HDPE bottle of 1000 with screw cap and desiccant Tentatively Approved View Label Efavirenz Capsules Cipla limited Goa (Unit VII) Plot no. L-147 - 147-1, Verna Industrial Estate, Verna Salcette, Goa, India. 403722 No Single Yes For Pediatric patients at least 3 months of age and weighing at least 7.5 kg. Efavirenz capsules should be stored at 25°C (77° F); excursions permitted to 15–30° C (59–86° F). 24 Not Scored Tentatively Approved 8/03/2009 India https://www.cipla.com/en/contact-us.html 99
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
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
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
022459 Tentatively Approved Lamivudine and Tenofovir Disoproxil Fumarate Tablets 300 mg/300 mg Hetero Labs Limited Unit III NDA Hetero Labs Limited Hetero Labs Limited Unit III and Unit- V 11/05/2009 HDPE bottles of 30, 60 and 100 with child-resistant/continuous thread plastic caps, pulp liner, filler, and desiccant. HDPE bottles of 500 with continuous thread plastic caps, pulp liner, filler and desiccant. Tentatively Approved View Label Lamivudine and Tenofovir Disoproxil Fumarate Tablets HETERO LABS LIMITED UNIT-III 22-110, Industrial Development Area Jeedimetla, Hyderabad, Telanagana, India. 500055 HETERO LABS LIMITED UNIT V Sy. No.: 439, 440, 441 & 458, TSIIC Formulation SEZ Polepally Village, Jadcherla Mandal Mahabubnagar, Telangana, India. 509301 No 2-Fixed Dose Combination Yes For Pediatric patients at least 16 years of age and weighing at least 35 kg. Store below 30°C. 24 Not Scored Tentatively Approved 11/05/2009 India https://www.heteroworld.com/contact-us.php 103 Yes
090371 Tentatively Approved Lopinavir and Ritonavir Tablets 200 mg/50 mg, 100 mg/25 mg Cipla Limited ANDA Cipla Limited Cipla Limited 11/20/2019 HDPE bottles of 120 of 200 mg/50 mg tablets. HDPE bottles of 60 of 100 mg/25 mg tablets. Tentatively Approved View Label Lopinavir and Ritonavir Tablets Cipla limited, Patalganga Cipla Limited, A-42, MIDC, Dist: Raigad, Patalganga, Maharashtra, India. 410220 No 2-Fixed Dose Combination Yes For Pediatric patients at least 6 months of age and weighing at least 15 kg. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). 24 Not Scored Tentatively Approved 11/20/2009 India https://www.cipla.com/en/contact-us.html 104
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
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
022299 Tentatively Approved Nevirapine tablet for Oral Suspension 50 mg Aurobindo Pharma Limited NDA Aurobindo Pharma Limited Aurobindo Pharma USA, Inc. 02/24/2010 HDPE bottles of 30 and 180. Tentatively Approved View Label Nevirapine Tablet for Oral Suspension Aurobindo Pharma Limited Unit-III, Sy. No.313 & 314, Bachupally, Bachupally Mandal, Medchal-Malkajgiri District, 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). 24 Scored Tentatively Approved 2/24/2010 India https://www.aurobindousa.com/contact-us/ 108 Yes
090636 Approved Tenofovir Disoproxil Fumarate Tablets 300 mg Hetero Labs Limited Unit III ANDA Hetero Labs Limited Unit III Camber Pharmaceuticals, Inc 01/26/2018 HDPE bottles of 30, 60, 100, 500, and 1000. Approved View Label Tenofovir Disoproxil Fumarate Tablets Hetero Labs Limited Unit-III Plot No. 22-110, Industrial Development Area Jeedimetla, Hyderabad, Telanagana, India. 500055 No Single Yes For Pediatric patients at least 2 years of age and weighing at least 17 kg. Store at 20 to 25°C (68 to 77°F). 24 Not Scored Approved 1/26/2018 Tentatively Approved 4/2/2010 India https://www.heteroworld.com/contact-us.php 109 Yes
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
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
022479 Withdrawn Lamivudine and Stavudine Tablets 150 mg/30 mg Hetero Labs Limited Unit III NDA Withdrawn Lamivudine and Stavudine Tablets No 2-Fixed Dose Combination Yes Not Scored Withdrawn 11/3/2017 Tentatively Approved 5/17/2010 https://www.heteroworld.com/contact-us.php 112
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
022541 Withdrawn Lamivudine and Stavudine Tablets 150 mg/30 mg Macleods Pharmaceuticals Limited NDA Withdrawn Lamivudine and Stavudine Tablets No 2-Fixed Dose Combination Yes Not Scored Withdrawn 10/10/2017 Tentatively Approved 8/5/2010 http://www.macleodspharma.com/UnitedStates.asp 114
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
022537 Withdrawn Lamivudine, Nevirapine, and Stavudine Tablets 150 mg/200 mg/30 mg Macleods Pharmaceuticals Limited NDA Withdrawn Lamivudine, Nevirapine, and Stavudine Tablets No 3-Fixed Dose Combination Yes Not Scored Withdrawn 10/10/2017 Tentatively Approved 8/30/2010 http://www.macleodspharma.com/UnitedStates.asp 116
200244 Withdrawn Lamivudine, Nevirapine, and Stavudine Tablets 150 mg/200 mg/30 mg Hetero Labs Limited Unit III NDA Withdrawn Lamivudine, Nevirapine, and Stavudine Tablets No 3-Fixed Dose Combination Yes Not Scored Withdrawn 11/3/2017 Tentatively Approved 9/10/2010 https://www.heteroworld.com/contact-us.php 117
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
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 Tentatively Approved 9/29/2010 India https://www.heteroworld.com/contact-us.php 119 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 Tentatively Approved 10/18/2010 India http://www.strides.com/contact.aspx 120 Yes
090561 Approved Zidovudine Tablets 300 mg Cipla Limited ANDA Cipla Limited Cipla Limited 10/27/2010 HDPE Bottles of 60 and 1000. Unit dose boxes of 100 tablets. Approved View Label Zidovudine Tablets Cipla Limited, Unit -VII Plot No. S-103 to S- 105, S-107 to S-112 & L-147, L-147/1 to L-147/3, L-147/A & L-138 Verna Industrial Estate, Verna, Salcette, Goa – 403 722, India No Single Yes For Pediatric patients at least 4 weeks of age. Store at 20 to 25°C (68 to 77°F). 24 Not Scored Approved 10/27/2010 India https://www.cipla.com/en/contact-us.html 121
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
022344 Approved Lamivudine and Tenofovir Disoproxil Fumarate Tablets 300 mg/300 mg Aurobindo Pharma Limited NDA Aurobindo Pharma Limited Aurobindo Pharma USA, Inc. 05/15/2018 HDPE bottle of 30 with an induction seal, desiccant, & child-resistant cap. Approved View Label Lamivudine and Tenofovir Disoproxil Fumarate Tablets Aurobindo Pharma Limited Unit-VII, Sy.No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No. S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India.509302. No 2-Fixed Dose Combination Yes For Pediatric patients weighing at least 35 kg. Store below 30°C (86°F). 24 Not Scored Approved 5/15/2018 Tentatively Approved 1/07/2011 India https://www.aurobindousa.com/contact-us/ 124 No
078348 Withdrawn Abacavir Sulfate Oral Suspension 20 mg/mL Cipla Limited ANDA Withdrawn Abacavir Sulfate Oral Solution No Single Yes Not Scored Withdrawn 05/18/2016 Tentatively Approved 2/16/2011 https://www.cipla.com/en/contact-us.html 125
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
200623 Tentatively Approved Lamivudine and Tenofovir Disoproxil Fumarate Tablets 300 mg/300 mg Cipla Limited NDA Cipla Limited Cipla Limited 03/04/2011 HDPE bottles of 30 and 500 with desiccant, heat-seal, and non child-resistant closure. Tentatively Approved View Label Lamivudine and Tenofovir Disoproxil Fumarate Tablets Cipla limited, D-7, MIDC Industrial Area, Kurkumbh; Pune, Maharashtra, India. 413802 No 2-Fixed Dose Combination Yes For Pediatric patients at least 12 years of age and weighing at least 35 kg. Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). 24 Not Scored Tentatively Approved 3/04/2011 India https://www.cipla.com/en/contact-us.html 127
022547 Tentatively Approved Abacavir Sulfate Tablets for Oral Suspension Dispersible tablets 60 mg Cipla Limited NDA Cipla Limited Cipla Limited 03/04/2011 HDPE bottles of 60 with desiccant, heat-sealed liner, and Non-CRC or CRC caps Tentatively Approved View Label Abacavir Sulfate Tablets for Oral Suspension Cipla Limited, A-33 MIDC, Patalganga Industrial Area, District: Raigad Patalganga, Maharashtra, India. 410220 No Single Yes For Pediatric patients at least 3 months of age. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59° to 86°F). 24 Scored Tentatively Approved 3/04/2011 India https://www.cipla.com/en/contact-us.html 128
091168 Approved Emtricitabine Capsules 200 mg Cipla Limited ANDA Cipla Limited Cipla USA, Inc. 07/02/2018 HDPE bottles of 30 and 1000. Approved View Label Emtricitabine Capsules Cipla Limited, Unit VII, Unit-VII, Plot No.: L147 to L-147/1 Verna Industrial Estate Verna, Salcette, Goa India 403722 No Single Yes For Pediatric patients at least 3 months of age and weighing at least 33 kg. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F - 86°F). 24 Not Scored Approved 7/2/2018 Tentatively Approved 3/29/2011 India https://www.cipla.com/en/contact-us.html 129
202007 Tentatively Approved Abacavir Sulfate and Lamivudine Tablets for Oral Suspension 60 mg/30 mg Cipla Limited NDA Cipla Limited Cipla Limited 05/12/2011 HDPE bottles of 60 and 120 with desiccant and non child-resistant caps. Blister pack cartons of 60 (6X10). Tentatively Approved View Label Abacavir Sulfate and Lamivudine Tablets for Oral Suspension Cipla Limited, A-33/A-42, A-2 MIDC, Patalganga Industrial Area, District: Raigad, Patalganga, Maharashtra, India. 410220 No 2-Fixed Dose Combination Yes For Pediatric patients at least 3 months of age. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). 24 Scored Tentatively Approved 5/12/2011 India https://www.cipla.com/en/contact-us.html 130
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
091579 Tentatively Approved Efavirenz Tablets 600 mg Macleods Pharmaceuticals Limited ANDA Macleods Pharmaceuticals Limited Macleods Pharma USA, Inc. 08/29/2011 HDPE bottles of 30. Tentatively Approved View Label Efavirenz Tablets Macleods Pharmaceuticals Limited Block N2, Village -Theda, Post Office - Lodhimajra, Tehsil - Baddi. Tehsil Baddi, District Solan, Himchal Pradesh, India 174101. No Single Yes For Pediatric patients at least 3 months of age and weighing at least 3.5 kg. Store at 20 to 25°C (68 to 77°F); excursions permitted from 15 to 30°C (59° to 86°F). 24 Not Scored Tentatively Approved 8/29/2011 India http://www.macleodspharma.com/UnitedStates.asp 132 Yes
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 Co-Packaged No Not Scored Withdrawn 04/6/2017 Tentatively Approved 9/8/2011 https://www.mylan.com/en/contact-mylan 133
201151 Withdrawn Lamivudine and Zidovudine Tablets 30 mg/60 mg Cipla Limited NDA Withdrawn Lamivudine and Zidovudine Tablets No 2-Fixed Dose Combination Yes Not Scored Withdrawn 11/12/2019 Tentatively Approved 9/22/2011 https://www.cipla.com/en/contact-us.html 134
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
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 to 86°F). Not Scored Tentatively Approved 11/18/2011 India https://www.mylan.com/en/contact-mylan 136 Yes
202157 Tentatively Approved Lamivudine, Nevirapine, and Zidovudine Tablets 150 mg/200 mg/300 mg Hetero Labs Limited Unit III NDA Hetero Labs Limited Hetero Labs Limited Unit III 11/18/2011 HDPE bottles of 60, 100, and 500. Blister pack cartons of 80 (8 x10) both PVC and PVC/PVdC. Tentatively Approved View Label Lamivudine, Nevirapine, and Zidovudine Tablets Hetero Labs Limited Unit III Plot No. 22-110, Part-II, IDA Jeedimetla, Hyderabad, Telangana, India. 500055 Hetero Labs Limited Unit - V Sy. No.: 439, 440, 441 & 458, TSIIC Formulation SEZ Polepally Village, Jadcherla Mandal Mahabubnagar, Telangana, India. 509301. No 3-Fixed Dose Combination Yes For Pediatric patients weighing at least 30 kg. Store below 30°C. 36 Not Scored Tentatively Approved 11/18/2011 India https://www.heteroworld.com/contact-us.php 137 Yes
201806 Tentatively 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 12/22/2011 HDPE bottles of 30. Tentatively 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 35 kg. Store below 30°C. 24 Not Scored Tentatively Approved 12/22/2011 India https://www.heteroworld.com/contact-us.php 138 Yes
202042 Tentatively 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. Tentatively Approved View Label Efavirenz Capsules Micro Labs Limited Plot No: S-155 to S-159 & N1, Phase III & Phase IV Verna Industrial Estate, Verna, Goa, India. 403722. No Single Yes For Pediatric patients at least 3 years of age and weighing at least 10 kg. Store at 25°C (77°F); excursions permitted to 15 - 30° C (59°-86°F) Not Scored Tentatively Approved 1/19/2012 India http://www.microlabsusa.com/contactus 139 Yes
091144 Approved Abacavir and Lamivudine Tablets 600 mg/300 mg Cipla Limited ANDA Cipla Limited Cipla USA, Inc. 03/28/2017 HDPE bottles 30. Unit dose bottles of 30 tablets (3X10). Approved View Label Abacavir Sulfate and Lamivudine Tablets Cipla limited, Patalganga Cipla Limited, Unit 1, A-33, MIDC, Dist: Raigad, Patalganga, Maharashtra, India. 410220 Cipla Limited, Goa Unit VII Plot No. S- 103 to S- 105, S-107 to S-112 & L-147, L-147/1 to L- 147/3, L-147/A & L-138 Verna Industrial Estate, Verna, Salcette Verna. Goa, India. 403722. No 2-Fixed Dose Combination Yes For Pediatric patients weighing at least 25 kg. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59° to 86°F). 24 Not Scored Approved 3/28/2017 Tentatively Approved 1/31/2012 India https://www.cipla.com/en/contact-us.html 140
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
202589 Tentatively Approved Lamivudine, Nevirapine, and Zidovudine Tablets 150 mg/200 mg/300 mg Macleods Pharmaceuticals Limited NDA Macleods Pharmaceuticals Limited Macleods Pharmaceuticals Limited 02/08/2012 HDPE bottles of 60 with induction seal and a child-resistant closure Tentatively Approved View Label Lamivudine, Nevirapine, and Zidovudine Tablets Macleods Pharmaceuticals Limited Premier Industrial Estate, Kachigam Plot No. 25 - 27, Survey No. 366, Daman, Daman, India. 396210 Macleods Pharmaceuticals Limited Village Theda, Post Office Lodhimajra, Tehsil Baddi, District Solan Block N2. Baddi, Himachal Pradesh, India. 174101. No 3-Fixed Dose Combination Yes For Pediatric patients weighing at least 30 kg. Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). 24 Not Scored Tentatively Approved 2/08/2012 India http://www.macleodspharma.com/UnitedStates.asp 142 Yes
091593 Tentatively Approved Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 600 mg/200 mg/300 mg Cipla Limited ANDA Cipla Limited Cipla Limited 02/27/2012 HDPE bottles of 30 with three silica gel desiccant and a non child-resistant closure. Tentatively Approved View Label Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets Cipla limited, Plot no. L-147 to L-147-1 (Unit VII) Verna Industrial Estate Verna, Salcette, Goa, India. 403722. No 3-Fixed Dose Combination Yes For Pediatric patients weighing at least 40 kg. Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). 36 Not Scored Tentatively Approved 2/27/2012 India https://www.cipla.com/en/contact-us.html 143
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 caps or Non-Child Resistant caps. HDPE bottles of 1000-tablet HDPE containers with filler, desiccant (silica gel), and Non-Child Resistant caps. Blister pack cartons of 60 with 6 Tentatively Approved View Label Nevirapine Tablets for Oral Suspension Cipla Limited, Patalganga unit II, A-42, A-2 MIDC, Patalganga Industrial Area, District: Raigad Patalganga, Maharashtra, India. 410220. No Single Yes For pediatric patients at least 15 days of age or older. Store at 25°C (77°F); excursions permitted 15°C to 30°C (59°F to 86°F). 24 Scored Tentatively Approved 4/30/2012 India https://www.cipla.com/en/contact-us.html 144
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
203080 Approved Nevirapine Tablets 200 mg Micro Labs Limited India ANDA Micro Labs Limited Micro Labs USA, Inc. 05/22/2012 HDPE bottles of 60. Blister packs of 10 in cartons of 60 (6X10). Approved View Label Nevirapine Tablets Micro Labs Limited Verna Industrial Estate, Phase III & Phase IV Plot No. S-l55 to S-159 & N1 Verna, Goa, India. 403722 No Single Yes For pediatric patients at least 15 days of age or older. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). 48 Scored Approved 5/22/2012 India http://www.microlabsusa.com/contactus 146 Yes
091677 Tentatively 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 05/23/2012 HDPE Bottles 60 and 120 with child resistant closure. Tentatively 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 Tentatively Approved 5/23/2012 India https://www.heteroworld.com/contact-us.php 147 Yes
091475 Tentatively 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) 05/29/2012 HDPE bottles of 240 mL with Expanded PE Wad. HDPE bottles of 240 mL with Induction Sealing FSE Wad. Tentatively 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 Tentatively Approved 5/29/2012 India https://www.heteroworld.com/contact-us.php 148 Yes
200406 Tentatively Approved Lamivudine Tablets 150 mg, 300 mg Micro Labs Limited India ANDA Micro Labs Limited Micro Labs USA Inc. 05/30/2012 HDPE bottle of 30, 60, and 90. Blister Pack of 10 and cartons of 5 blister packs (5 X 10). Tentatively Approved View Label Lamivudine Tablets Micro Labs Limited Plot No: S-155 to S-159 & N1, Phase III & Phase IV Verna Industrial Estate, Verna, Goa, India. 403722. No Single Yes For Pediatric patients at least 3 months of age and weighing at least 14 kg. Store in tightly closed bottles at 25°C (77°F). Not Scored Tentatively Approved 5/30/2012 India http://www.microlabsusa.com/contactus 149 Yes
202814 Tentatively Approved Lamivudine and Zidovudine Tablets for Oral Suspension 30 mg/60 mg Cipla USA Inc. NDA Cipla Limited Cipla Limited 06/15/2012 HDPE bottles of 60 with desiccant, induction seals, screw caps, and Child-resistant caps or Non-CRC caps. HDPE bottles of 1000 tablets with desiccant, induction seals, screw caps, and Non-CRC caps. 60 tablet PVC/PE/PVDC/Aluminum blister pack cartons with Tentatively Approved View Label Lamivudine and Zidovudine Tablets for Oral Suspension Cipla Limited Plot No. L-147 to L-147-1 (Unit VII), Verna Industrial Estate, Verna, Goa, India. 403722. No 2-Fixed Dose Combination Yes For Pediatric patients at least 3 months of age and weighing at least 5 kg. Do not store above 30°C. 24 Scored Tentatively Approved 6/15/2012 India https://www.cipla.com/en/contact-us.html 150
202301 Tentatively Approved Efavirenz Tablets 600 mg Micro Labs Ltd India ANDA Micro Labs Limited Micro Labs USA Inc. 06/20/2012 HDPE bottles of 30, 60, and 90; with induction seal and child-resistant cap. Blister Pack of 10 and cartons of 5 blister packs (5 X 10). Tentatively Approved View Label Efavirenz Tablets Micro Labs Limited Plot No. S-155 to S-159 & N1, Verna Industrial Estate, Phase III & Phase IV Verna, Goa, India 403722 No Single Yes For Pediatric patients at least 3 months of age and weighing at least 3.5 kg. Efavirenz tablets USP should be stored at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). 36 Not Scored Tentatively Approved 6/20/2012 India http://www.microlabsusa.com/contactus 151 Yes
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
091203 Withdrawn Lopinavir and Ritonavir Oral Solution 80 mg/20 mg per mL Cipla Limited ANDA Withdrawn Lopinavir and Ritonavir Oral Solution No 2-Fixed Dose Combination Yes Not Scored Withdrawn 2/25/2016 Tentatively Approved 6/29/2012 https://www.cipla.com/en/contact-us.html 153
201107 Approved Abacavir Oral Solution 20 mg/mL Hetero Labs Ltd Unit III ANDA Hetero Labs Ltd Unit III Camber Pharmaceuticals, Inc. 09/26/2016 HDPE bottles 240 mL with Expanded PE Wad. HDPE bottles 240 mL with Induction Sealing FSE Wad. Approved View Label Abacavir Oral Solution Hetero Drugs Limited Unit III Plot No. 22-110, Part-II, IDA Jeedimetla, Hyderabad, Telangana India. -500 055. No Single Yes For Pediatric patients at least 3 months of age. Store at 20 - 25°C (68 - 77°F). DO NOT FREEZE. May be refrigerated. 24 Not Scored Approved 9/26/2016 Tentatively Approved 7/2/2012 India https://www.heteroworld.com/contact-us.php 154 Yes
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 tightly closed. 24 Scored Tentatively Approved 9/21/2012 India http://www.strides.com/contact.aspx 155 Yes
203076 Tentatively Approved Lamivudine, Nevirapine and Zidovudine Tablets 30 mg/50 mg/60 mg Cipla Ltd NDA Cipla Limited Cipla Ltd 10/16/2012 HDPE bottles of 60 or 1000 tablets with filler, desiccant, and induction seals. Tentatively Approved View Label Lamivudine, Nevirapine and Zidovudine Tablets for Oral Suspension Cipla Limited., (Unit VII) Plot no. L-147, L147-1 Verna Industrial Estate, Verna, Salcette, Goa. 403722 India. No 3-Fixed Dose Combination Yes For Pediatric patients at least 3 months of age and weighing at least 5 kg. Store below 30°C (86°F). 24 Scored Tentatively Approved 10/16/2012 India https://www.cipla.com/en/contact-us.html 156
204119 Tentatively Approved Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets 600 mg/300 mg/300 mg Hetero Labs Limited Unit III NDA Hetero Labs Limited and Annora Pharma Private Hetero Labs Limited 06/30/2017 HDPE bottles of 30, 90 and 100 tablets with desiccant and child resistant closure Tentatively Approved View Label Efavirenz, Lamivudine, and Tenofovir disoproxil fumarate Tablets Annora Pharma Private Limited Survey No. 261, Annaram Village, Gummadidala Mandal Sangareddy, Telangana - 502313, India (IND). Hetero Labs Limited Unit III 22-110, I D A, Jeedimetla, Hyderabad -500 055, Andhra Pradesh, India. No 3-Fixed Dose Combination Yes For Pediatric patients greater than 40 kg. Store below 30°C (86°F). 24 Not Scored Tentatively Approved 06/30/2017 India https://www.heteroworld.com/contact-us.php 157 Yes
203283 Tentatively Approved Lamivudine and Tenofovir Disoproxil Fumarate Tablets 300 mg/300 mg Macleods Pharmaceuticals Ltd NDA Macleods Pharmaceuticals Limited Macleods Pharmaceuticals Ltd 11/08/2012 HDPE bottles of 30 tablets with silica gel desiccant, induction seal. Blister pack of 100 tablets. Tentatively Approved View Label Lamivudine and Tenofovir disoproxil fumarate Tablet Macleods Pharmaceuticals Limited, Plot No. 25 – 27, Survey No. 366, Premier Industrial Estate, Kachigam, Daman – 396210, India Macleods Pharmaceuticals Limited, Village Theda, Post Office Lodhimajra, Tehsil- Baddi, District- Solan, Himachal Pradesh – 174101, India. No 2-Fixed Dose Combination Yes For Pediatric patients greater than 12 years of age and weighing at least 35 kg. Store below 30°C (86°F). 24 Not Scored Tentatively Approved 11/8/2012 India http://www.macleodspharma.com/UnitedStates.asp 158 Yes
203041 Approved Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate Tablets 600 mg/200 mg/300 mg Aurobindo Pharma Limited ANDA Aurobindo Pharma Limited Unit - VII Aurobindo Pharma USA, Inc. 09/04/2018 HDPE Bottles of 30 tablets with child resistant seal. Approved View Label Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate Tablets Aurobindo Pharma Limited, Unit - VII, Sy. No. 411/P, 425/P, 434/P, 435/P & 458/P, Plot No. S1 (Part) SEZ (Pharma), TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahaboob Nagar (DT), Andhra Pradesh - 509 302, India. No 3-Fixed Dose Combination Yes For Pediatric patients weighing at least 40 kg. Store at 20 - 25°C (68 - 77°F). 24 Not Scored Approved 9/4/2018 Tentatively Approved 4/2/2013 India https://www.aurobindousa.com/contact-us/ 159 Yes
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
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 Aurobindo Pharma Limited, Unit-X Plot No.16, APIIC Multi Product SEZ, Menakuru, Naidupeta, Nellore, Andhra Pradesh, 524421 India Aurobindo Pharma Limited, Unit-VII Sy.No. 411/P, 425/P, 434/P, 435/P & 458/P, Plot No. S1 (Part) SEZ (Pharma), TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabub Nagar (District), Mahabub Nagar, Telangana -509302, India No 3-Fixed Dose Combination Yes For Pediatric patients weighing at least 40 kg. Store below 30°C (86°F). 36 Not Scored Approved 8/15/2018 Tentatively Approved 6/26/2013 India https://www.aurobindousa.com/contact-us/ 161 Yes
091055 Tentatively 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 07/31/2013 HDPE bottles of 30 with desiccant and child-resistant closure. Tentatively 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 at least 12 years of age and weighing at least 35 kg. Store at 20 to 25°C (68 to 77°F). 24 Not Scored Tentatively Approved 7/31/2013 India http://www.strides.com/contact.aspx 162 Yes
204505 Tentatively Approved Lamivudine and Tenofovir Disoproxil Fumarate Tablets Co-packaged with Nevirapine Tablets USP 300 mg/300 mg + 200 mg Aurobindo Pharma Limited NDA Aurobindo Pharma Limited Aurobindo Pharma USA, Inc. 10/18/2013 Cartons of 30 day supply containing 15 blister packs each containing two one day cards, each card with two nevirapine tablets and one lamivudine/Tenofovir disoproxil fumarate tablet. Tentatively Approved View Label Lamivudine/Tenofovir Disoproxil Fumarate + Nevirapine Tablets Aurobindo Pharma Limited, Unit-VII Sy.No. 411/P, 425/P, 434/P, 435/P & 458/P, Plot No. S1 (Part) SEZ (Pharma), APIIC, Green Industrial Park, Polepally, Mahaboob Nagar (DT), Jedcherla, Andhra Pradesh 509302, India Yes 3-Fixed Dose Combination Yes For Pediatric patients at least 16 years of age and weighing at least 35 kg. Store below 30°C (86°F). 24 Not Scored Tentatively Approved 10/18/2013 India https://www.aurobindousa.com/contact-us/ 163 No
203053 Tentatively Approved Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 600 mg/200 mg/300 mg HETERO LABS LTD UNIT V ANDA Hetero Labs Limited HETERO LABS LTD UNIT V 10/31/2013 HDPE bottles of 30 with desiccant and child-resistant closure. Tentatively 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 No 3-Fixed Dose Combination Yes For Pediatric patients 12 years of age and older who weigh at least 40 kg. Store below 30°C (86°F). 36 Not Scored Tentatively Approved 10/31/2013 India https://www.heteroworld.com/contact-us.php 164 Yes
204568 Tentatively Approved Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets 600 mg/300 mg/300 mg Cipla Limited NDA Cipla Limited Cipla Limited 12/30/2013 HDPE bottles of 30 count with non child-resistant closure Tentatively Approved View Label Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablet Cipla Limited, Plot No A-42 (Unit-II), MIDC Patalganga, 410 220, District Raigad, Maharashtra, India Cipla Limited, Unit VII Plot No.S-103 toS-105, S-107 to S-112, L-147, L-147/1 to L-147/3, L-147/A & L-138 Verna Industrial Estate, Verna, Salcette, Goa - 403 722, India Cipla Ltd. Unit VII PD II, S-103 to S-105, S-107 to S-112, L-138, L-147, L-147/1 to L-147/3, L-147 A Verna Industrial Estate, Verna Salcette, Goa- 403722, India No 3-Fixed Dose Combination Yes For Pediatric patients at least 16 years of age and weighing at least 40 kg. Store at room temperature below 30°C (86°F). 24 Not Scored Tentatively Approved 12/30/2013 India https://www.cipla.com/en/contact-us.html 165
204806 Approved Atazanavir Capsules 100 mg, 150 mg, 200 mg, 300 mg Aurobindo Pharma Limited ANDA Aurobindo Pharma Limited Aurobindo Pharma USA, Inc. 06/25/2018 100 mg: HDPE Bottles of 60 and 500. 3 X 10 Unit-dose Capsules. 150 mg: HDPE Bottles of 60, 180 and 500. 3 X 10 Unit-dose Capsules. 200 mg: HDPE Bottles of 60, 180 and 500. 3 X 10 Unit-dose Capsules. 300 mg: HDPE Bottles of 30, 90 and 500. 3 X 10 Unit-dos Approved View Label Atazanavir Capsules Aurobindo Pharma Limited Unit-VII, Sy.No.411/P, 425/P, 434/P, 435/P & 458/P, Plot No. S1 (Part), SEZ (Pharma) TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar (District) Mahabubnagar, Telangana, India.509302. No Single Yes For pediatric patients at least 6 years of age and weighing at least 15 kg. Store at 20 to 25°C (68 to 77°F). 24 Not Scored Approved 6/25/2018 Tentatively Approved 1/31/2014 India https://www.aurobindousa.com/contact-us/ 166 No
204914 Tentatively Approved Lamivudine and Zidovudine Tablets 30 mg/60 mg Mylan Laboratories Ltd NDA Mylan Laboratories Limited Mylan Laboratories Ltd 02/04/2014 HDPE bottle packs of 60 tablets with desiccant. Tentatively Approved View Label Lamivudine and Zidovudine Tablet for Oral Suspension Mylan Laboratories Limited (FDF- 2) Plot # H-12 and H-13, MIDC Waluj Industrial Area, Aurangabad- 431 136 Maharashtra, India Mylan Laboratories Limited (FDF-3) Plot No. 11, 12 and 13, Indore Special Economic Zone Pharma Zone, Phase-II, Sector-III, Pithampur Dhar district, Madhya Pradesh, India 454775 No 2-Fixed Dose Combination Yes For Pediatric patients at least 3 months of age and weighing at least 5 kg. Store at room temperature below 30°C (86°F). 24 Scored Tentatively Approved 2/4/2014 India https://www.mylan.com/en/contact-mylan 167 Yes
090958 Tentatively Approved Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 mg/300 mg Cipla Limited ANDA Cipla Limited Cipla USA, Inc. 02/26/2014 HDPE bottles of 30 with child-resistant closure and desiccant. Tentatively Approved View Label Emtricitabine and Tenofovir Disoproxil Fumarate Tablets Cipla Limited Unit-VII, Plot No.: L147 to L-147/1 Verna Industrial Estate Verna, Salcette, Goa, India. 403722. 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 Tentatively Approved 2/26/2014 India https://www.cipla.com/en/contact-us.html 168
205355 Tentatively Approved Lamivudine and Tenofovir Disoproxil Fumarate Tablets, co-packaged with Nevirapine Tablets 300 mg/300 mg + 200 mg Hetero Labs Ltd Unit III NDA Hetero Labs Limited Unit III Hetero Labs Ltd Unit III 03/14/2014 Cartons of 10 single-day blister cards each blister card containing one tablet tenofovir disoproxil fumarate/lamivudine and two tablets of nevirapine. (Alu-Alu with desiccant)(3X10). Tentatively Approved View Label Lamivudine and Tenofovir Disoproxil Fumarate Tablets, co-packaged with Nevirapine Tablets Tablets Hetero Labs Limited Unit III Plot No. 22-110, Part-II, Industrial Development Area Jeedimetla, Hyderabad, Telangana, India 500055 Yes Co-Packaged Yes For Adolescents patients at least 16 years of age and weighing at least 35 kg. Store at room temperature below 30°C (86°F). 24 Not Scored Tentatively Approved 3/14/2014 India https://www.heteroworld.com/contact-us.php 169 No
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
203232 Approved Tenofovir Disoproxil Fumarate Tablets 300 mg Macleods Pharmaceuticals Limited ANDA Macleods Pharmaceuticals Limited Macleods Pharma USA, Inc. 01/26/2018 HDPE bottles of 30 with desiccant. Approved View Label Tenofovir Disoproxil Fumarate Tablets Macleods Pharmaceuticals Limited Plot No 25-27, Survey No. 366, Premier Industrial Estate, Kachigam Daman, Daman, India. 396210 No Single Yes For Pediatric patients at least 2 years of age and weighing at least 10 kg. Store tenofovir disoproxil fumarate tablets 20 to 25°C (68 to 77 °F), excursions permitted to 15 to 30°C (59 to 86° F). 24 Not Scored Approved 1/26/2018 Tentatively Approved 8/5/2014 India http://www.macleodspharma.com/UnitedStates.asp 171 Yes
205861 Tentatively Approved Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets 600 mg/300 mg/300 mg Macleods Pharmaceuticals Ltd NDA Macleods Pharmaceuticals Limited Macleods Pharma USA, Inc. 08/14/2014 HDPE bottle packs of 30, 90, 100, and 180 tablets with silica gel desiccant and induction seal. Tentatively Approved View Label Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets 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 weighing at least 40 kg. Store at room temperature below 30°C (86°F). 24 Not Scored Tentatively Approved 8/14/2014 India http://www.macleodspharma.com/UnitedStates.asp 172 Yes
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 Co-Packaged Yes Not Scored Withdrawn Effective 4/6/2017 Tentatively Approved 9/4/2014 https://www.mylan.com/en/contact-mylan 174
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 Co-Packaged Yes Not Scored Withdrawn 4/6/2017 Tentatively Approved 9/4/2014 https://www.mylan.com/en/contact-mylan 175
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 Co-Packaged Yes Not Scored Withdrawn Effective 4/6/2017 Tentatively Approved 9/12/2014 https://www.mylan.com/en/contact-mylan 176
205412 Tentatively Approved Abacavir Sulfate and Lamivudine Tablets 600 mg/300 mg Hetero Labs Limited Unit V ANDA Hetero Labs Limited Unit V Hetero Labs Limited Unit V 09/25/2014 HDPE bottles of 30 with child-resistant caps, pulp liners, and desiccant. Tentatively Approved View Label Abacavir Sulfate and Lamivudine Tablets Hetero Labs Limited Unit V Sy. No.: 439, 440, 441 & 458, TSIIC Formulation SEZ Polepally Village, Jadcherla Mandal, Mahabubnagar, Telangana, India. 509301 No 2-Fixed Dose Combination Yes For Pediatric patients weighing at least 25 kg. Store at 20 to 25°C (68° to 77°F). 24 Not Scored Tentatively Approved 9/25/2014 India https://www.heteroworld.com/contact-us.php 177 Yes
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
204311 Tentatively Approved Abacavir and Lamivudine Tablets 60 mg/30 mg Mylan Laboratories Limited NDA Mylan Laboratories Limited Mylan Laboratories Limited 10/23/2014 HDPE bottles of 60 with induction seal and child-resistant cap. Tentatively Approved View Label Abacavir and Lamivudine Tablets for Oral Suspension Mylan Laboratories Limited Plot No. F/4, 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, Maadhya 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 179 Yes
204287 Tentatively 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, 90, and 180 tablets with desiccant and child-resistant closure with pulp and heat seal liner . Tentatively 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 25°C (77°F); excursions permitted to 15–30°C (59–86°F). 24 Not Scored Tentatively Approved 11/28/2014 India http://www.macleodspharma.com/UnitedStates.asp 180 Yes
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 Tentatively Approved 2/10/2015 India http://ecipharma.com/contactus.aspx 181
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 product to high humidity outside the original or USP e 24 Not Scored Tentatively Approved 3/27/2015 India https://www.cipla.com/en/contact-us.html 182
205040 Tentatively Approved Ritonavir Tablets 25 mg, 50 mg Cipla Ltd NDA Cipla Limited Cipla Ltd 03/29/2015 HDPE bottles containing 60 tablets, with non child-resistant closure Tentatively Approved View Label Ritonavir Tablets Cipla Limited., Unit II, A-42, MIDC, Patalganga , District Raigad, Maharashtra, India. 410220 No Single Yes For Pediatric patients at least 3 years of age or older. Store below 30°C (86°F). 24 Not Scored Tentatively Approved 3/29/2015 India https://www.cipla.com/en/contact-us.html 183
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 high humidity outside the original container for longer than 2 weeks is not recommended. 24 Not Scored Tentatively Approved 5/21/2015 India https://www.cipla.com/en/contact-us.html 184
207064 Tentatively Approved Nevirapine Extended-Release Tablets 400 mg Cipla Limited ANDA Cipla Limited Cipla Limited 06/30/2015 HDPE bottles of 30 with child-resistant cap. HDPE bottle of 480. Blister cartons of 50 (5X10). Tentatively Approved View Label Nevirapine Tablets, Extended-Release Cipla Limited Goa Plot No. L-147- 147/1 (Unit VII) Verna Industrial Estate Verna, Goa India. -403722 No Single Yes For Pediatric patients at least 6 years of age with a body surface area (BDA) of 1.17m2. Store tablets at 25C (77°F); with excursions permitted to 15-30°C (59-86°F). 24 Not Scored Tentatively Approved 6/30/2015 India https://www.cipla.com/en/contact-us.html 185
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
207369 Tentatively Approved Abacavir and Lamivudine Tablets 60 mg/30 mg Hetero Labs Ltd Unit V NDA Hetero Labs Limited Unit V Hetero Labs Ltd Unit V 11/13/2015 HDPE bottles containing 30 tablets with desiccant (silica gel), pulp liner, and child-resistant closure. Blister card of 10 unit dose tablets and cartons of 10 blisters with each blister pack containing 10 doses (100 unit doses total). Tentatively Approved View Label Abacavir and Lamivudine Tablets Hetero Labs Limited Unit V Sy. No.: 439, 440, 441 & 458, TSIIC Formulation SEZ Polepally Village, Jadcherla Mandal Mahabubnagar, Telangana. India 509301. No 2-Fixed Dose Combination Yes For Pediatric patients at least three months of age. Store below 30°C (86°F). 24 Scored Tentatively Approved 11/13/2015 India https://www.heteroworld.com/contact-us.php 187 No
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
204739 Tentatively Approved Lopinavir and Ritonavir Tablets 100 mg/25 mg, 200 mg/50 mg Macleods Pharmaceuticals Ltd ANDA Macleods Pharmaceuticals Limited Macleods Pharma USA, Inc. 03/07/2016 HDPE bottle packs of 60 with a child-resistant closure, heat seal linger, and silica gel sachet for 100 mg/ 25 mg dose. HDPE bottle packs of 120 , with a child-resistant closure, heat seal linger, and silica gel sachet for 200 mg/ 50 mg dose. Tentatively Approved View Label Lopinavir and Ritonavir Tablets Macleods Pharmaceuticals Limited, Block N2, Village Theda, Post Office Lodhimajra, Tehsil Baddi, District Solan, Himachal Pradesh – 174101 India. No 2-Fixed Dose Combination Yes For Pediatric patients at least 14 days or older. Store at 20 to 25°C (68 to 77°F). excursions permitted to 15 to 30°C (59 to 86°F). 24 Not Scored Tentatively Approved 3/7/2016 India http://www.macleodspharma.com/UnitedStates.asp 189 Yes
091677 Tentatively Approved Lopinavir and Ritonavir Tablets 100 mg/25 mg Hetero Labs Limited Unit-III ANDA Hetero Labs Limited Unit-III Hetero Labs Limited Unit-III 08/11/2016 HDPE bottles of 120 with child-resistant closure. Tentatively 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 Tentatively Approved 8/11/2016 India https://www.heteroworld.com/contact-us.php 190 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. No Single Yes For Pediatric patients weighing at least 30 kg. Store below 30°C (86°F). Not Scored Tentatively Approved 9/19/2016 India https://www.aurobindousa.com/contact-us/ 191 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
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 03/10/2017 India https://www.mylan.com/en/contact-mylan 193 Yes
207189 Tentatively Approved Darunavir Tablets 75 mg, 150 mg, 400 mg, 600 mg Cipla Limited ANDA Cipla Limited Cipla Limited 03/16/2017 HDPE bottle packs of 480 with a non-child-resistant closure for the 75 mg tablets, HDPE bottle packs of 240 with a non-child-resistant closure for the 150 mg tablets, HDPE bottle packs of 60 with a non-child-resistant closure for the 400 mg and 600 mg tab Tentatively Approved View Label Darunavir Tablets Cipla Limited, Plot no a-33, a-42, a-2, Patalganga Industrial Area, Patalganga District - Raigad, Maharashtra IN 410220 No Single Yes For Pediatric patients three years of age or older and weighing at least 10 kg. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). 24 Not Scored Tentatively Approved 3/16/2017 India https://www.cipla.com/en/contact-us.html 194
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, closed with a 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). 24 Scored Tentatively Approved 04/06/2017 India https://www.cipla.com/en/contact-us.html 195
207315 Withdrawn Lamivudine and Tenofovir Disoproxil Fumarate Tablets 75 mg/75 mg Hetero Labs Limited Unit III NDA Withdrawn Lamivudine and Tenofovir Disoproxil Fumarate Tablets No 2-Fixed Dose Combination Yes Not Scored Withdrawn 10/24/2019 Tentatively Approved 5/5/2017 https://www.heteroworld.com/contact-us.php 196
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
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
207684 Approved Nevirapine Oral Suspension 50 mg/5 mL Cipla Ltd ANDA Cipla Ltd Cipla USA Inc. 08/03/2017 HDPE bottles with child resistant closure and liner containing 100 or 240 mL of suspension along with oral syringe. Approved View Label Nevirapine Oral Suspension Unit 1, Plot No.9, 10 & 15 Indore Special Economic Zone, Phase II Pithampur, District Dhar, Pin Code: 454775. Madhya Pradesh, India. No Single Yes For Pediatric patients at least 15 days of age. Store at 25°C (77°F); excursions permitted to 15-30°C. 24 Not Scored Approved 8/3/2017 India https://www.cipla.com/en/contact-us.html 199
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 and 90 tablets with desiccant, induction seal and child resistant cap. Tentatively Approved View Label Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets 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 Aurobindo Pharma Limited, Unit-X Plot No.16, APIIC Multi Product SEZ, Menakuru, Naidupeta, Nellore, Andhra Pradesh, 524421 India No 3-Fixed Dose Combination Yes For Pediatric patients at least 12 years of age and weighing 40 kg or greater. Store below 30°C (86°F). 24 Not Scored Tentatively Approved 8/18/2017 India https://www.aurobindousa.com/contact-us/ 200 Yes
206451 Tentatively Approved Atazanavir and Ritonavir tablets 300 mg/100 mg Cipla Limited NDA Cipla Limited Cipla Limited 10/27/2017 HDPE bottles containing 30 tablets with desiccant and non child-resistant cap and aluminum-aluminum blister packs containing 100 tablets (10 blister packs of 10 tablets each). Tentatively Approved View Label Atazanavir and Ritonavir Tablets Cipla Ltd. Plot No A – 42 (Unit II), MIDC, Patalganga, District Raigad, Maharashtra, Pin code: 410 220. India. No 2-Fixed Dose Combination Yes For Pediatric patients at least 6 years of age and weighing 35 kg or greater. Store below 30°C (86°F). 24 Not Scored Tentatively Approved 10/27/2017 India https://www.cipla.com/en/contact-us.html 201
208656 Tentatively Approved Abacavir Tablets for Oral Suspension 60 mg Micro Labs limited India NDA Micro Labs limited Micro Labs Limited USA 11/28/2017 HDPE bottles containing 60 tablets with desiccant, induction seal, filler, and child-resistant cap Tentatively Approved View Label Abacavir Tablets for Oral Suspension Micro Labs Limited Plot No: S-155 to S-159 & N1, Phase III & Phase IV, Verna Industrial Estate, Verna, Goa- 403722. India (IND). No Single Yes For Pediatric patients three months and older weighing at least 5 kg. Store below 30°C (86°F). 24 Scored Tentatively Approved 11/28/2017 India http://www.microlabsusa.com/contactus 202 No
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
206725 Tentatively Approved Abacavir Sulfate Tablets 300mg Micro Labs Ltd India ANDA Micro Labs Limited Micro Labs USA Inc. 12/22/2017 HDPE bottle packs of 60 with child-resistant closure and blister packs of 10's. Tentatively Approved View Label Abacavir Sulfate Tablets Micro Labs limited, S-155-159, Verna Industrial Estate, Venra, Goa 403722, India No Single Yes For pediatric patients aged 3 months or older. Store at controlled room temperature of 20 to 25°C (68 to 77°F). 24 Scored Tentatively Approved 12/22/2017 India http://www.microlabsltd.com/contact 204 No
205493 Tentatively Approved Lamivudine and Tenofovir Disoproxil Fumarate Tablets 300 mg/300 mg Micro Labs Limited India NDA Micro Labs Limited India Micro Labs USA. Inc. 01/25/2018 HDPE bottles containing 30 or 100 tablets with induction seal, desiccant, cotton coil, and child-resistant cap Tentatively Approved View Label Lamivudine and Tenofovir Disoproxil Fumarate Tablets Micro Labs Limited Plot No: S-155 to S-159, Phase III, Verna Industrial Estate, Verna, Goa - 403 722, India No 2-Fixed Dose Combination Yes For Pediatric patients at least 12 years of age or weighing at least 35 kg. Store below 30°C (86°F). 24 Not Scored Tentatively Approved 1/25/2018 India http://www.microlabsusa.com/contactus 205 No
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). Not Scored Tentatively Approved 2/9/2018 India https://www.mylan.com/en/contact-mylan 206 No
205389 Tentatively Approved Efavirenz Tablets 50 mg, 100 mg, 200 mg Micro Labs Limited India NDA Micro Labs Limited Micro Labs USA , Inc. 02/23/2018 HDPE bottles containing 30 or 90 tablets with induction seal and child-resistant cap. Cartons containing 100 unit-dose tablets in 10 PVC aluminum foil blister cards. Tentatively Approved View Label Efavirenz Tablets Micro Labs Limited Plot No: S-155 to S-159, Phase III, Verna Industrial Estate, Verna, Goa- 403722 No Single Yes For Pediatric patients at least three months old and weighing at least 3.5 kg. Store below 30°C (86°F). 36 Not Scored Tentatively Approved 2/23/2018 India http://www.microlabsusa.com/contactus 207 Yes
209658 Tentatively Approved Dolutegravir Tablets 50 mg Cipla Limited ANDA Cipla Limited Cipla Limited 03/05/2018 Bottles of 30, 90, and 100 with child-resistant closure and bottles of 500 with non-child-resistant closure Tentatively Approved View Label Dolutegravir Tablets Cipla Limited Unit IV, Plot No. 9, 10 &15 Indore Special Economic Zone, Phase II, Pithampur, District Dhar, Pin Code: 454775. Madhya Pradesh, India. No Single Yes For weighing Pediatric patients weighing at least 40 kg. Store at 25°C (77°F); excursions permitted between 15 to 30°C (59 to 86°F). 24 Not Scored Tentatively Approved 3/5/2018 India https://www.cipla.com/en/contact-us.html 208
210254 Tentatively Approved Darunavir Tablets 800 mg Cipla Limited ANDA Cipla Limited Cipla Limited 03/14/2018 HDPE bottles of 30 with child resistant closure and non child resistant screw. Tentatively Approved View Label Darunavir Tablets Cipla Limited, Plot no a-33, a-42, a-2, Patalganga Industrial Area, Patalganga District - Raigad, Maharashtra IN 410220 No Single Yes For Pediatric patients three years of age or older and weighing at least 10 kg. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). 24 Not Scored Tentatively Approved 3/14/2018 India https://www.cipla.com/en/contact-us.html 209
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
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
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
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 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 12 years of age and weighing 40 kg or greater. Store below 30°C (86°F). To protect from moisture, dispense the packages of 30, 60 and 90 tablets in their original bottles. Do not remove desiccant. 24 Not Scored Tentatively Approved 8/8/2018 India https://www.heteroworld.com/contact-us.php 213 Yes
205626 Approved Lamivudine, Nevirapine, and Zidovudine fixed dose combination Tablets 150 mg/200 mg/300 mg Micro Labs Limited NDA Micro Labs Limited Micro Labs USA Inc. 08/13/2018 HDPE bottles containing 60 tablets with induction seal and child-resistant closure. Approved View Label Lamivudine, Nevirapine, and Zidovudine Tablets Micro Labs Limited Plot No: S-155 to S-159 & N1, Phase III & IV, Verna Industrial Estate, Verna, Goa - 403722. India (IND). No 3-Fixed Dose Combination Yes For Pediatric patients weighing at least 35 kg. Store below 30°C (86°F). Store in tight, light-resistant containers. 24 Not Scored Approved 8/13/2018 India http://www.microlabsusa.com/contactus 214 No
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
204396 Tentatively Approved Emtricitabine Capsules 200 mg Micro Labs Limited ANDA Micro Labs Limited Micro Labs USA Inc. 12/04/2018 HDPE bottle packs of 30 with child-resistant closure and blister packs of 10s. Tentatively Approved View Label Emtricitabine Capsules Micro Labs Limited Plot No: S-155 to S-159 & N1, Phase III & IV, Verna Industrial Estate, Verna, Goa - 403722. India (IND). No Single Yes For pediatric patients from 3 months through 17 years of age, who weigh more then 33 kg and who can swallow an intact capsule. Store at 25°C (77°F) excursions permitted to 15 to 30°C (59 to 86°F). 24 Not Scored Tentatively Approved 12/4/2018 India http://www.microlabsltd.com/contact 216 No
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 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 40 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 Tentatively Approved 2/1/2019 India http://www.lauruslabs.com/contact-us 217 Yes
210649 Approved Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets 400 mg/300 mg/300 mg  Macleods Pharmaceuticals Ltd. NDA Macleods Pharmaceuticals Ltd. Macleods Pharma USA Inc. 03/15/2019 HW HDPE bottles containing 30 or 90 with desiccant, induction seal, and child resistant caps. HW HDPE bottles of 180 with desiccant and induction seal. Approved View Label Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets Macleods Pharmaceuticals Limited Survey No 366, Premier Industrial Estate, Kachigam Plot No. 25 - 27 Daman, Daman, India.396210. No 3-Fixed Dose Combination Yes Approved for use in pediatrics patients with a weight greater than 35 kg. Store below 30°C (86°F). Store in original bottle, protect from moisture, and keep bottle tightly closed. Do not remove desiccant. Keep out of reach of children. 24 Not Scored Approved 3/15/2019 India http://www.macleodspharma.com/UnitedStates.asp 218 Yes
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. 03/15/2019 HW HDPE bottles containing 30, 90, 100 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 ltd. Plot No. 25-27, Survey No. 366, Premier Industrial Estate, Kachigam, Daman - 396210, India (IND) No 3-Fixed Dose Combination Yes Approved for use in pediatrics patients with a weight greater than 40 kg. Store below 30°C (86°F). Store in original bottle, protect from moisture, and keep bottle tightly closed. Do not remove desiccant. 24 Not Scored Tentatively Approved 3/15/2019 India http://www.macleodspharma.com/UnitedStates.asp 219 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). 24 Not Scored Tentatively Approved 5/16/2019 India http://www.lauruslabs.com/contact-us 220 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
212179 Tentatively Approved Dolutegravir Tablets 50 mg Micro Labs Ltd ANDA Micro Labs Limited Micro Labs USA Inc. 09/13/2019 HDPE bottles of 30, 60, and 90; with induction seal and child-resistant cap. Tentatively Approved View Label Dolutegravir Sodium Tablets Micro Labs limited Plot No. S-155 to S-159 & N1, Phase III & Phase IV, Verna Industrial Estate, Verna, Goa, India 403722 No Single Yes For Pediatric patients weighing at least 40 kg. Store at 25°C (77°F), excursions permitted between 15° to 30°C (59° to 86°F). 24 Not Scored Tentatively Approved 9/13/2019 India http://www.microlabsltd.com/contact 222 No
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). 24 Not Scored Approved 7/26/2019 India http://www.lauruslabs.com/contact-us * 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 or 90 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. 24 Not Scored Tentatively Approved 4/13/2020 South Korea and India https://www.celltrion.com/en-us/contact/customer 223 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). 24 Not Scored Approved 5/14/2020 India http://www.lauruslabs.com/contact-us 224 Yes
213038 Approved Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets 400 mg/300 mg/300 mg Laurus Labs Limited ANDA Laurus Labs Limited Laurus Generics Inc. 05/14/2020 HDPE Bottles of 30, 90, or 180 Tablets with desiccant, induction seal, and child-resistant cap. Approved View Label Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets Laurus Labs Limited, (VSP-2) Plot No. 19, 20 and 21, Western Sector, APSEZ, Atchutapuram Visakhapatnam, Andhra Pradesh, India 531011 No 3-Fixed Dose Combination Yes For Pediatric patients weighing at least 35 kg. Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). 24 Not Scored Approved 5/14/2020 India http://www.lauruslabs.com/contact-us 225 Yes
203442 Approved Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 mg/300 mg Macleods Pharmaceuticals Ltd. ANDA Macleods Pharmaceuticals Ltd. Macleods Pharma USA, Inc. 05/15/2020 HDPE Bottles of 30 or 90 Tablets with desiccant, induction seal, and child-resistant cap. HDPE Bottles of 180 Tablets with desiccant, induction seal, and non-child-resistant cap. Approved View Label Emtricitabine and Tenofovir Disoproxil Fumarate Tablets Macleods Pharmaceuticals ltd. Plot No. 25-27, Survey No. 366, Premier Industrial Estate, Kachigam, Daman - 396210, India (IND) No 2-Fixed Dose Combination Yes For Pediatric patients weighing at least 17 kg. and can swallow a tablet. Store below 30°C (86°F). Keep continaer tightly closed. Dispense only in original container. 24 Not Scored Approved 5/15/2020 India http://www.macleodspharma.com/UnitedStates.asp 226 Yes

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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