International Programs

Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan

In May 2004, in support of the President's Emergency Plan, FDA announced a new initiative to help ensure that those being served by the Presidents' Plan would receive safe, effective, and quality manufactured antiretroviral drugs. This new initiative included an expedited review process. Through guidance and an active outreach program to the pharmaceutical industry, FDA actively encouraged any sponsors worldwide to submit U.S. marketing applications for single entity, fixed dose combination (FDC), and co-packaged versions of previously approved antiretroviral therapies - even if there was still patent or exclusivity market protection for the product in the U.S.

FDA's special initiative for these products has involved four main components: 

  1. FDA reviews the marketing applications using its normal standards for authorization. If the product still has marketing protection in the U.S., FDA issues a "tentative approval" rather than a "full" approval. The "tentative" approval signifies that the product meets all safety, efficacy, and manufacturing quality standards for marketing in the U.S., and, but for the legal market protection, it would be on the U.S. market. USAID allows, under the President's Emergency Plan, purchase of any product that has either a "full" or "tentative" FDA approval. In this manner, the only products being offered under this program to the focus countries are products that we would offer our own citizens. 
     
  2. Very importantly, FDA works intensively with manufacturers who have not interacted with FDA previously to help them prepare an FDA application and to prepare for the requisite FDA inspections of their clinical trials and manufacturing facilities. 
     
  3. Due to the significant public health impact of these products, FDA prioritizes the review of these marketing submissions and has met its announced commitment to complete the reviews in as little as two to six weeks after submission of a high-quality application. 
     
  4. Finally, FDA has engaged proactively with its counterpart regulatory agencies in the President's Plan focus countries and with the WHO Pre-Qualification Unit to help them understand the initiative and the science that stands behind the regulatory decisions FDA is making so that they can more readily utilize the FDA efforts for local registration.
     

FDA Antiretrovirals Approved and Tentatively Approved in Association with the President's Emergency Plan Expedited Review Process

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#Application NumberEstablished NameStrengthDosage FormSupplierManufacturing Site Drug ProductPackaging Material and
Pack
Date of FDA Approval or Tentative Approval
190ANDA 208355Dolutegravir50 mgTabletsAurobindo Pharma LimitedAurobindo Pharma Limited
Unit-VII (SEZ), Mahaboob Nagar (Dt) – 509302
India
HDPE bottle packs of 30 with a child-resistant closureTentatively Approved
9/19/2016
189ANDA 091677Lopinavir and Ritonavir100 mg /25 mgTabletsHetero Labs Limited Unit-IIIHetero Labs Limited Unit-III
22-110, Industrial Development Area, Jeedimetla, Hyderabad – 500 055
India
HDPE bottle packs of 60 and 120 with child-resistant closureTentatively Approved
8/11/2016
188ANDA 204739Lopinavir and Ritonavir100 mg / 25 mg and 200 mg / 50 mgTabletsMacleods Pharmaceuticals LimitedMacleods Pharmaceuticals Limited
Block N2, Village Theda, Post Office Lodhimajra, Tehsil Nalagarh, District Solan, Himachal Pradesh – 174101
India
HDPE bottle packs of 60 and 120 respectively, with a child-resistant closure, heat seal linger and silica gel sachetTentatively Approved
3/7/2016
187NDA 207369Abacavir and Lamivudine60 mg / 30 mgTabletsHetero Labs Limited Unit VHetero Labs Limited Unit V
SEZ Unit I in APIIC SEZ Polepally Village, Jadcherla Mandal Mahaboob Nagar-509 301
India
1) HDPE bottles containing 30 tablets with desiccant (silica gel), pulp liner, and child-resistant closure
2) 100-tablet Alu-Alu blisters pack cartons (10 tablets per card; 10 cards per carton)
Tentatively Approved 11/13/2015
186ANDA 207064Nevirapine400 mgTablets, Extended-ReleaseCipla LimitedCipla Limited
L138-147 L150 S103-105 S107-112 M61-63 Verna, Salcette, GOA
India
Blister packs of 10; HDPE bottle packs of 30 with child-resistant cap; HDPE bottle packs of 480 with non-child-resistant cap; and fibre drum of 10,000Tentatively Approved 6/30/2015
185NDA 205425Lopinavir and Ritonavir40 mg / 10 mgOral PelletsCipla LimitedCipla Limited Unit VII
L147 to L147-1 Industrial Area, Verna, Salcette Goa 403 722
India
HDPE bottles of 120 capsules containing the oral pellets, with desiccant, induction seal, and non-child-resistant closureTentatively Approved 5/21/2015
184NDA 205040Ritonavir Tablets25 mg / 50 mgTabletsCipla LimitedCipla Limited, Unit II
A-42, MIDC, Patalganga, District Raigad, Maharashtra
India
HDPE bottles containing 60 tablets, with non child-resistant closureTentatively Approved 3/29/2015
183ANDA 203759Ritonavir Tablets100 mgTabletsCipla LimitedCipla Limited
A-42, MIDC, Patalganga, Dist: Raigad, Maharashtra
India
HDPE bottle packs of 30 with 45 mm non-child-resistant closure and rayon SaniCoilTentatively Approved 3/27/2015
182ANDA 203586Lamivudine Tablets150 mgTabletsCentaur Pharmaceutical Private LimitedCentaur Pharmaceutical Private Limited
Plot #4, International Biotech Park Hinjewadi Phase II Pune, Maharashtra 411057 India
HDPE bottle packs of 60 with 33 mm child-resistant closureTentatively Approved 2/10/2015
181ANDA 205302Rilpivirine Tablets25 mgTabletsStrides Arcolab LimitedStrides Arcolab Limited
36/7, KRS Garden Suragajakkanahalli, Bangalore – 562106
India
HDPE bottle packs of 30 tablets with 33 mm child-resistant closureTentatively Approved 9/29/2015
180ANDA 204287Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets600 mg / 200 mg / 300 mgTabletsMacleods Pharmaceuticals LimitedMacleods Pharmaceuticals Limited
Plot No. 25-27, Survey No. 366, Premier Industrial Estate, Kachigam, Daman 396 210
India
HDPE bottle packs of 30 tablets with desiccant and child-resistant closure with pulp and head seal linerTentatively Approved 11/28/2014
179NDA 204311Abacavir and Lamivudine Tablets for Oral Suspension60 mg / 30 mgTablets for Oral SuspensionMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited
Plot # F/4 & F/12, Malegaon MIDC, Sinnar, Nashik District 422 113, Maharashtra
India
1) HDPE bottle packs of 60 tablets with cotton, screw caps, induction seals, and desiccant (silica gel)
2) HDPE bottle packs of 60 tablets with cotton, screw caps, and induction seals for commercial packaging
3) bulk package triple-laminated bag containing LDPE bags of 3,500 tablets (for repacking within 12 months) and desiccant
Tentatively Approved 10/23/2014
178NDA 204915Abacavir and Lamivudine Tablets for Oral Suspension120 mg / 60 mgTablets for Oral SuspensionMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited
H-12 & H-13, MIDC, Waluj, Aurangabad, 431136, Maharashtra
India
1) HDPE bottle packs of 30 tablets with cotton, induction seal and screw caps for commercial packaging
2) bulk package triple-laminated bag containing four LDPE bags of 2,000 tablets (for repacking within 6 months) and desiccant in a drum (total tablets 8,000)
Tentatively Approved 10/23/2014
177ANDA 205412Abacavir Sulfate and Lamivudine600 mg / 300 mgTabletsHetero Labs Limited Unit VHetero Labs Limited Unit-V
SEZ Unit I in APIIC SEZ, Polepally Village, Jadcherla (Mandal), Mahaboob Nagar (District) Andhra Pradesh - 509301
India
HDPE Bottles, 30’s, CRC Caps with pulp liners, desiccant
Blister packs, 10’s (Alu-Alu and PVC/PVdC-Alu)
Tentatively Approved 9/25/2014
176NDA 206042Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, Co-packaged with Nevirapine Tablets200 mg  / 300 mg co-packaged with 200 mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited
Plot # F/4 & F/12, Malegaon MIDC, Sinnar, Nashik District 422 113, Maharashtra
India
Cartons containing 5 blister packs (consisting of aluminum-aluminum blisters), each containing two 1-day cards, for a 10 day supply. Three cartons are further packaged together for a 30 day supplyTentatively Approved 9/12/2014
175NDA 206041Atazanavir Sulfate and Ritonavir Tablets, co-packaged with Lamivudine and Zidovudine Tablets300 mg / 100 mg co-packaged with 150 mg / 300 mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited
Plot # F/4 & F/12, Malegaon MIDC, Sinnar, Nashik District 422 113, Maharashtra
India
Cartons containing 5 blister packs (consisting of PVC/Aclar film and coated aluminum foil), each containing two 1-day cards, for a 10 day supply. Three cartons are further packaged together for a 30 day supplyTentatively Approved 9/4/2014
174NDA 206040Lamivudine and Zidovudine Tablets, Co-packaged with Efavirenz Tablets150 mg / 300 mg co-packaged with 600 mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited
Plot # F/4 & F/12, Malegaon MIDC, Sinnar, Nashik District 422 113, Maharashtra
India
10-day supply (5 two-day blister cards consisting of PVC/PvDC film and coated aluminum foil)Tentatively Approved 9/4/2014
173ANDA 205921Nevirapine400 mgExtended-release TabletsMylan Pharmaceuticals, Inc.Mylan Laboratories Limited
Plot # F-4 and F-12, Malegaon M.I.D.C., Sinnar, Nashik District, Maharashtra - 422113
India  
HDPE bottle, 30’s, cotton, CR and Non-CR caps with induction seals
Bulk package triple-laminated bag containing four LDPE bags of 800 tablets and desiccants (total tablets 3,200)
Tentatively Approved 8/26/2014
172NDA 205861Efavirenz, Lamivudine and Tenofovir disoproxil fumarate600 mg / 300 mg / 300 mgTabletsMacleods Pharmaceuticals LimitedMacleods Pharmaceuticals Limited
Block-N2, Village Theda, Post Office Lodhimajra, Tehsil Baddi, District Solan, Himachal Pradesh – 174101
India
HDPE bottle packs of 30 tablets with desiccant and induction sealTentatively Approved 8/14/2014
171ANDA 203232Tenofovir Disoproxil Fumarate300 mgTabletsMacleods Pharmaceuticals LimitedMacleods Pharmaceuticals Limited
Plot No 25-27. Survev No 366 Premrer industrral Estate, Kachigam Daman - 396210
India
HDPE bottle, 30’s, cotton, desiccant, CR caps with pulp and heat sealsTentatively Approved 8/5/2014
170NDA 205508Atazanavir Sulfate and Ritonavir300 mg / 100 mgTabletsEmcure Pharmaceuticals LimitedEmcure Pharmaceuticals Limited
Plot No. P-1 & P-2, I.T.B.T. Park Phase-II, MIDC, Hinjwadi Pune – 411 057, Maharashtra
India
HDPE bottles of 30-count with desiccant and induction sealed child-resistant closureTentatively Approved 3/17/2014
169NDA 205355Lamivudine and Tenofovir Disoproxil Fumarate Tablets, co-packaged with Nevirapine Tablets300 mg / 300 mg, co-packaged with 200 mgTabletsHetero Labs Limited Unit III
(formerly Hetero Drugs Limited)
 
Hetero Labs Limited Unit III
22-110, I D A, Jeedimetla, Hyderabad -500 055, Andhra Pradesh
India
Carton of 10 single-day blister cards (Alu-Alu with desiccant)Tentatively Approved 3/14/2014
168ANDA 090958Emtricitabine and Tenofovir Disoproxil Fumarate200 mg / 300 mgTabletsCipla LimitedCipla Limited
L-147 – L147-1 Verna Industrial Estate Verna Goa 403 722
India
HDPE Bottles, 30’s, non-CRC, silica gel bagsTentatively Approved 2/26/2014
167NDA 204914Lamivudine and Zidovudine30 mg / 60 mgTablets for Oral SuspensionMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited
Plot No: H-12 and H-13, MIDC Waluj Industrial Area, Aurangabad—431 136 Maharashtra
India
HDPE bottle packs of 60 tablets with desiccantTentatively Approved 2/4/2014
166ANDA 204806Atazanavir Sulfate100 mg / 150 mg / 200 mg / 300 mgCapsulesAurobindo Pharma LimitedAurobindo 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
100 mg: HDPE Bottles of 60 and 500
150 mg: HDPE Bottles of 60, 180 and 500
200 mg: HDPE Bottles of 60, 180 and 500
300 mg: HDPE Bottles of 30, 90 and 500
With Induction Sealing Wad 10’s Count Blister Pack, PVC film and aluminum foil
Tentatively Approved 1/31/2014
165NDA 204568Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate600 mg / 300 mg /300 mgTabletsCipla LimitedCipla Limited., Unit II, A-42, MIDC, Patalganga, District Raigad, Maharashtra
India
HDPE bottles of 30 count with non child-resistant closureTentatively Approved 12/30/2013
164ANDA 203053Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate600 mg / 200 mg / 300 mgTabletsHetero Labs Limited Unit VHetero Labs Limited, Unit-V SEZ Unit I in APIIC Formulation Polepally Village, Jadcherla Mandal Survey No. 439, 440, 441 & 458 Mahaboob Nagar District Andhra Pradesh 509 301
India
HDPE Bottles 30's and 500's, CRC caps with pulp liners, dessicantTentatively Approved 10/31/2013
163NDA 204505Lamivudine and Tenofovir Disoproxil Fumarate Tablets, Co-packaged with Nevirapine Tablets USP300 mg /300 mg co-packaged with 200 mgTabletsAurobindo Pharma LimitedAurobindo 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
30-day supply (15 two-day blister cards with a desiccant layer)Tentatively Approved 10/18/2013
162ANDA 091055Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg / 300 mg200 mg / 300 mgTabletsStrides Arcolab LimitedStrides Arcolab Limited
36/7, Suragajakkanahalli, Indlavadi cross, Anekal Taluk Bangalore – 562106
India
HDPE Bottles - 30's, Screw Cap, Liner, DessicantTentatively Approved 07/31/2013
161NDA 22343Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate600 mg / 300 mg / 300 mgTabletsAurobindo Pharma LimitedAurobindo Pharma Limited Unit-VII (SEZ) Mahaboob Nagar (Dt) AP-509302
India
HDPE bottles of 30 count (with child-resistant closure) and 500 count tablets (with non-child-resistant closure), both with heat sealed liner and silica gel desiccantTentatively Approved 06/26/2013
160NDA 202529Lamivudine and Tenofovir disoproxil fumarate300 mg / 300 mgTabletsRanbaxy Laboratories LimitedRanbaxy Laboratories Limited Shasun Chemicals and Drugs Limited, R.S. No 32, 33 & 34, PIMS Road, Periyakalapet, Pondicherry – 605 014
India
HDPE bottles of 30 tablets with silica gel desiccant, and child resistant closureTentatively Approved 05/17/2013
159ANDA 203041Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate600 mg / 200 mg / 300 mgTabletsAurobindo Pharma LimitedAurobindo 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 509 302
India
HDPE Bottles 30's and 100's
38 mm – 400 CR Closure with Induction sealing wad
53 mm – 400 CR Closure with Induction sealing wad Heat seal liner HS123
3 g and 10 g Silica Gel Sachet
Tentatively Approved 04/02/2013
158NDA 203283Lamivudine and Tenofovir disoproxil fumarate300 mg / 300 mgTabletsMacleods Pharmaceuticals LimitedMacleods Pharmaceuticals Limited Plot No. 25 – 27, Survey No. 366, Premier Industrial Estate, Kachigam, Daman – 396210
India
HDPE bottles of 30 tablets with silica gel desiccant, induction seal, and child resistant closureTentatively Approved 11/8/2012
157NDA 204119Efavirenz, Lamivudine, and Tenofovir disoproxil fumarate600 mg / 300 mg / 300 mgTabletsHetero Labs Limited Unit III
(formerly Hetero Drugs Limited)
Hetero Labs Limited Unit III 22-110, IDA, Jeedimetla, Hyderabad – 500 055HDPE bottles of 30 tablets with desiccant and child resistant closureTentatively Approved 11/8/2012

STATUS: Complete Response. Effective 5/25/2016, this product is no longer Tentatively Approved and not eligible for procurement under the PEPFAR program.
156NDA 203076Lamivudine, Nevirapine and Zidovudine30 mg / 50 mg/ 60 mgTablets for Oral SuspensionCipla LimitedCipla Limited, Plot No. L-147, L147-1 (Unit VII), Verna Industrial Estate, Verna Salcette Goa, 403 722
India
1) HDPE bottles of 60 tablets with filler, desiccant (silica gel), induction seals, and CRC caps or Non-CRC caps
2) HDPE bottles of 1000 tablets with filler, desiccant (silica gel), induction seals, and Non-CRC caps
Tentatively Approved 10/16/2012
155NDA 202685Lamivudine, Nevirapine and Zidovudine30 mg / 50 mg / 60 mgTablets for Oral SuspensionStrides Arcolab LimitedStrides Arcolab Limited, 36/7, Suragajakkanahalli, Indlavadi cross, Anekal Taluk, Bangalore - 562 106
India
HDPE bottles of 60 tablets with desiccant sachets, induction seals and CRC caps or Non-CRC capsTentatively Approved 09/21/2012
154ANDA 201107Abacavir20 mg / mLOral SolutionHetero Labs Limited Unit III
(formerly Hetero Drugs Limited)
 
Hetero Labs Limited, Unit III 22-110 Industrial development Area Jeedimetla, Hyderabad 500 055 Andhra Pradesh
India
HDPE opaque bottles, 240 mLTentatively Approved 07/02/2012
153ANDA 091203Lopinavir and Ritonavir80 mg / 20 mg per mLOral SolutionCipla Limited
 
Cipla Limited Plot No. L-139, S-103 & M-62, Verna Industrial Estate, Verna Salcette, Goa, Pin -403722
India
Amber Colored PET bottles, 160 mLTentatively Approved 06/29/2012
152ANDA 202990Efavirenz600 mgTabletsEdict Pharmaceuticals Private Limited
 
Edict Pharmaceuticals Private Limited
1/58 Pudupakkam Main Road, Pudupakkam Chennai 603 103
India
HDPE 30'sTentatively Approved 06/25/2012
151ANDA 202301Efavirenz600 mgTabletsMicro Labs LimitedMicro Labs Limited
Plot No: S-155 to S-159, Phase III,
Verna Industrial Estate,
Salcettte, Goa
India
HDPE Bottle Pack of 30’s Tablets
HDPE Bottle Pack of 60’s Tablets
HDPE Bottle Pack of 90’s Tablets
Blister Pack of 10s Tablets
Tentatively Approved 06/20/2012
150NDA 202814Lamivudine and Zidovudine30 mg / 60 mgTablets for Oral SuspensionCipla LimitedCipla Limited,
L-147 to L-147.1 (Unit VII),
Verna Industrial Estate,
Verna Salcette, Goa 403 722
India
1) 60-tablet HDPE containers with desiccant (silica gel), induction seals, screw caps, and CRC caps or Non-CRC caps
2) 60-tablet PVC/PE/PVDC/Aluminum blister pack cartons with 6 x 10 unit of use tablet cards
3) 1000-tablet HDPE containers with desiccant (silica gel), induction seals, screw caps, and Non-CRC caps
4) Bulk package in a fiber drum containing 5,000 tablets in clear polythene bags (for repacking within 6 months)
Tentatively Approved 06/15/2012
149ANDA 200406Lamivudine150 mg and 300 mgTabletsMicro Labs LimitedMicro Labs Limited
Plot Number S-155 to S-159 Phase III,
Verna Industrial Estate, Verna, Goa- 403722
India
1. HDPE Bottle Pack of 30s Tablets
2. HDPE Bottle Pack of 60s Tablets
3. HDPE Bottle Pack of 90s Tablets
4. Blister Pack of 10s tablets
Tentatively Approved 05/30/2012
148ANDA 091475Lamivudine10 mg / mlOral SolutionHetero Labs Limited Unit III
(formerly Hetero Drugs Limited)
M/S Hetero Drugs Limited Unit-III 22-110, Industrial Development Area Jeedimetla, Hyderabad - 500 055HDPE Bottle - 240 mlTentatively Approved 05/29/2012
147ANDA 091677Lopinavir and Ritonavir200 mg /50 mgTabletsHetero Labs Limited Unit III
(formerly Hetero Drugs Limited)
M/S Hetero Drugs Limited Unit III,
22 - 110, Industrial development Area, Jeedimetla, Hyderabad -500 055, Andhra Pradesh
India
HDPE Bottles 60’s
HDPE Bottles 120’s
Unit-Dose 10’s Blister (Alu-Alu)
Unit-Dose 10’s Blister (Alu-PVC/PVdC)
Tentatively Approved 05/23/2012
146ANDA 203080Nevirapine200 mgTabletsMicro Labs LimitedMicro Labs Limited Plot Number S-155 to S-159 Phase III, Verna Industrial Estate Verna, Goa 403 722
India
HDPE Bottles - 60's Unit Dose Blister Packs Foil - 10'sApproved 05/22/2012

Approved 05/22/12
145ANDA 203176Nevirapine200 mgTabletsScieGen Pharmaceuticals, Inc.Sciegen Pharmaceuticals Inc,
20, Davids Drive
Hauppauge, New York 11788
USA
HDPE Bottles 30's and 500'sTentatively Approved 04/30/2012

Approved 05/22/12
144NDA 202212Nevirapine50 mg and 100 mgTablets for Oral SuspensionCipla LimitedCipla Limited
A-42, MIDC, Patalganga 410220, Dist: Raigad, Maharashtra
India
1) 60-tablet HDPE containers with filler, desiccant (silica gel), and Child Resistant caps or Non-Child Resistant caps
2) 1000-tablet HDPE containers with filler, desiccant (silica gel), and Non-Child Resistant caps
3) 60-tablet blister pack cartons with 6 x 10 unit of use tablet card
Tentatively Approved 04/30/2012
143ANDA 091593Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate600 mg / 200 mg / 300 mgTabletsCipla LimitedCipla Limited
L-147 – L147-1
Verna Industrial Estate,
Verna Goa
India
HDPE Bottles 30'sTentatively Approved 02/27/2012
142NDA 202589Lamivudine, Nevirapine, and Zidovudine150 mg / 200 mg / 300 mgTabletsMacleods Pharmaceuticals LimitedMacleods Pharmaceuticals Limited
Plot No. 25-27, Survey No. 366
Premier Industrial Estate, Kachigam,
Daman – 396210
India
HDPE bottles of 60 tablets with induction seal and a child-resistant closureTentatively Approved 02/08/2012
141NDA 202381Abacavir Sulfate and Lamivudine60 mg / 30 mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited,
Plot # F-4 & F-12
Malegaon MIDC,
Sinnar
Nashik-422 113, Maharashtra
India
HDPE bottles of 30 tablets (with induction seals and desiccant) and a bulk package triple-laminated bag containing four bags of 7000 tablets and desiccantTentatively Approved 01/31/2012
140ANDA 091144Abacavir Sulfate and Lamivudine600 mg (base) / 300 mgTabletsCipla LimitedCipla Limited A-33, MIDC, Patalganga, Dist: Raigad, Maharashtra
India
HDPE bottles 30's, Unit dose blister packs 3 x 10'sTentatively Approved 01/31/2012
139ANDA 0202042Efavirenz50 mg / 200 mgCapsulesMicro Labs LimitedMicro Labs Limited Plot Number S-155 to S-159 Phase III, Verna Industrial Estate, Verna, Goa-403722
India
HDPE Containers 30's, 60's 90's Polypropylene CRC Cap Head Induction Foil SealTentatively Approved 01/19/2012
138ANDA 201806Emtricitabine / Tenofovir Disoproxyl Fumarate200 mg / 300 mgTabletsHetero Labs Limited Unit III
(formerly Hetero Drugs Limited)
M/S Hetero Labs Limited, Unit III
22-110 Industrial development Area
Jeedimetla, Hyderabad 500 055
HDPE Bottles 30'sTentatively Approved 12/22/2011
137NDA 202157Lamivudine / Nevirapine / Zidovudine150 mg / 200 mg / 300 mgTabletsHetero Labs Limited Unit III
(formerly Hetero Drugs Limited)
Hetero Labs Limited
(Unit III)
22-110, Industrial Development Area Jeedimetla, Hyderbad-500 055 Andhra Pradesh
India
HDPE containers of 60, 100, and 500 tablets and blister pack cartons of 80 (8 x10) unit of use tabletsTentatively Approved 11/18/2011
136NDA 22282Atazanavir Sulfate / Ritonavir300 mg / 100 mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited
Plot # F-4 & F-12 Malegaon MIDC, Sinnar Nashik-422 113, Maharashtra
India
HDPE bottles of 30, 90, and 120 tablets (with induction seals and desiccant) and a bulk package triple-laminated bag containing four bags of 500 tablets and desiccantTentatively Approved 11/18/2011
135ANDA 202058Zidovudine300mgTabletsHEC Pharm, Inc.Sunshine Lake Pharma Co. Ltd.
1 Northern Industry Road Song Sham Lake, DongGuan GuangDong Province P. R. China 523808
HDPE Bottles 60'sTentatively Approved 10/07/2011
134NDA 201151Lamivudine and Zidovudine30 mg / 60mgTabletsCipla LimitedCipla Limited, L-139 to L-146 (Unit-III), Verna Industrial Estate, Verna Salcette, Goa 403 722
India
1. HDPE containers of 60 tabs or 1000 tabs with induction seals, desiccant (silica gel), and Non-CRC caps
2. Blister pack cartons of 60 (6x10) unit of use tablets
Tentatively Approved 09/22/2011
133NDA 202171Lamivudine / Tenofovir Disoproxil Fumarate Tablets Co-packaged with Nevirapine Tablets300 mg / 300mg Co-packaged with 200 mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited
Village Theda, Post Office Lodhimajra
Tehsil Nalagarh, District Solan
Himachal Pradesh – 174101
India
Foil lined blister packsTentatively Approved 09/08/2011
132ANDA 091579Efavirenz600 mgTabletsMacleods Pharmaceuticals LimitedMacleods Pharmaceuticals Limited
Village Theda, Post Office Lodhimajra
Tehsil Nalagarh, District Solan
Himachal Pradesh – 174101
India
HDPE Bottles, 30'sTentatively Approved 08/29/2011
131ANDA 090742Tenofovir Disoproxil Fumarate300 mgTabletsStrides Arcolab LimitedStrides Arcolab Limited
36/7 Suragajakkanahalli
Indlavadi Cross, Anekal Taluk
Bangalore 562 106
India
HDPE Bottles 30'sTentatively Approved 05/25/2011
130NDA 202007Abacavir Sulfate and Lamivudine60 mg / 30 mgTablets for Oral SuspensionCipla LimitedCipla Limited
A-33, MIDC, Patalganga 410220, Dist: Raigad, Maharashtra
India
1. HDPE containers of 60 tabs or 120 tabs with filler, desiccant (silica gel), and Non-CRC caps
2. Blister pack cartons of 60 (6x10) unit of use tablets
Tentatively Approved 05/12/2011
129ANDA 091168Emtricitabine200 mgCapsulesCipla LimitedCipla Limited
Manufactured Division, Verna Industrial Estate, Salcette, Goa - 403 722
India
HDPE Bottles, 30's and 1000'sTentatively Approved 03/29/2011
128NDA 22547Abacavir Sulfate60 mgTablets for Oral SuspensionCipla LimitedCipla Limited
A-33, MIDC, Patalganga 410220, Dist: Raigad, Maharashtra
India
HDPE containers of 60 tabs with desiccant, heat-sealed liner, and Non-CRC or CRC capsTentatively Approved 03/04/2011
127NDA 200623Lamivudine and Tenofovir Disoproxil Fumarate300 mg / 300 mgTabletsCipla LimitedCipla Limited
D-7, MIDC Industrial Area, Kurkumbh; Dist: Pune 413 802
India
HDPE containers with desiccant and heat-seal containing 30 tablets or 500 tabletsTentatively Approved 03/04/2011
126NDA 200732Zidovudine100 mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited
(Unit III)
F-4 & F-12 Malegaon MIDC Sinnar Nashik-422 113, Maharashtra India
HDPE container of 60 tablets with an induction seal and screw cap and bulk package containing 26,000 tabletsApproved 02/23/2011
125ANDA 078348Abacavir Sulfate20 mg (base) / mLOral SolutionCipla LimitedCipla Limited
L-139 to L-146 Verna Industrial Estate Goa – 403 722
India
100 mL and 240 mL HDPE bottlesTentatively Approved 02/16/2011
124NDA 22344Lamivudine and Tenofovir Disoproxil Fumarate300 mg / 300 mgTabletsAurobindo Pharma LimitedAurobindo Pharma Limited, Unit-VII (SEZ), Survey No. 411/P, 425/P, 434/P, 435/P & 458/P, Plot No. S1 (Part) Special Economic Zone (Pharma), APIIC, Green Industrial Park, Polepally Village, Jedcherla Mandal, Mahaboob Nagar (DT), Andhra Pradesh-509 302
India
1. HDPE container of 30 tabs with an induction seal, desiccant, & child-resistant cap
2. Bulk pagkages (for repacking within 6 months)
Tentatively Approved 01/07/2011
123NDA 200748Lamivudine and Zidovudine30 mg / 60 mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited
F-4 & F-12 Malegaon MIDC Sinnar Nashik-422 113, Maharashtra
India
HDPE container of 60 tablets with screw cap and bulk package in a LDPE bag containing 6,500 tabletsTentatively Approved 1/05/2011
122NDA 200733Abacavir Sulfate60 mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited
F-4 & F-12 Malegaon MIDC Sinnar Nashik-422 113, Maharashtra
India
HDPE container of 60 tablets with screw cap and bulk package in LDPE bags containing 28,000 tabletsTentatively Approved 11/29/2010
121ANDA 090561Zidovudine300 mgTabletsCipla LimitedCipla Limited Verna Industrial Estate Verna, Salcette, Goa – 403 722
India
HDPE Bottles; 60's , 1000's, Blister Pack: 10'sTentatively Approved 10/27/2010
120ANDA 079128Lamivudine and Zidovudine150 mg and 300 mgTabletsStrides Arcolab Limited36/7, Suragajakkanahalli Indlavadi cross Anekal Taluk Bangalore – 562106
India
HDPE Bottles 60'sTentatively Approved 10/18/2010
119ANDA 091560Abacavir Sulfate300 mgTabletsHetero Labs Limited Unit III
(formerly Hetero Drugs Limited)
Hetero Labs Limited, Unit III 22 - 110, Industrial development Area, Jeedimetla, Hyderabad -500 055 Andhra Pradesh
India
HDPE bottles: 60's, 100's, 500's Unit Dose Film Package: 10'sTentatively Approved 9/29/2010
118ANDA 0091611Atazanavir Sulfate150 mg and 300 mgCapsulesMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited, Plot # F-4 & F-12, Malegaon MIDC, Sinnar Nashik-422 113, Maharashtra
India
HDPE bottles, 30's for both the 150mg and 300 mg capsulesTentatively Approved  9/15/2010
117NDA 200244Lamivudine, Nevirapine, and Stavudine150 mg / 200 mg / 30 mgTabletsHetero Labs Limited Unit III
(formerly Hetero Drugs Limited)
Hetero Drugs Limited Unit III, 22 - 110, industrial development Area, Jeedimetla, Hyderabad - 500 055 Andhra Pradesh
India
HDPE containers of 60 tablets, 100 tablets, and 500 tabletsTentatively Approved 9/10/2010
116NDA 22537Lamivudine, Nevirapine, and Stavudine150 mg / 200 mg / 30 mgTabletsMacleods Pharmaceuticals LimitedMacleods Pharmaceuticals Limited Plot No. 25-27, Survey No. 366 Premier Industrial Estate, Kachigam Daman – 396210
India
HDPE container of 60 tablets and bulk package triple laminate pouch containing 1500 tabletsTentatively Approved  8/30/2010
115ANDA 200196Atazanavir Sulfate300 mgCapsulesEmcure Pharmaceuticals LimitedEmcure Pharmaceuticals Limited Plot No. P-1, 2, I.T. - B.T. Park, Phase II, MIDC, Hinjwadi, Pune - 411 057
India
30's HDPE BottlesTentatively Approved 8/19/2010
114NDA 22541Lamivudine and Stavudine150 mg / 30 mgTabletsMacleods Pharmaceuticals LimitedMacleods Pharmaceuticals Limited Plot No. 25-27, Survey No. 366 Premier Industrial Estate, Kachigam Daman – 396210
India
HDPE container of 60 tablets and bulk package triple laminate pouch containing 2000 tabletsTentatively Approved 8/05/2010
113NDA 200793Lamivudine, Nevirapine, and Zidovudine30mg / 50mg / 60mgTablet for Oral SuspensionMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited
Plot # F/4, F/12 Sinnar, Nashik District Maharashtra State
India
HDPE container of 60 tablets with screw cap and desiccant (silica gel)Tentatively Approved 7/08/2010
112NDA 22479Lamivudine and Stavudine150mg / 30mgTabletsHetero Labs Limited Unit III
(formerly Hetero Drugs Limited)
Hetero Labs Limited Unit III 22-110, I.D.A., Jeedimetla Jeedimeta, Hyderabad – 500 055 Andhra Pradesh
India
1. HDPE containers of 30, 60 and 100 tabs fitted with CRC plastic caps with pulp liner, filler and desiccant (silica gel) 2. HDPE containers of 500 tabs fitted with CT plastic caps with pulp liner, filler and desiccant (silica gel)Tentatively Approved 5/17/2010
111ANDA 091050Abacavir Sulfate300mgTabletsStrides Arcolab LimitedStrides Arcolab Ltd. 36/7 Suragajakkanahalli, Indlavadi cross, Anekal Taluk Bangalore - 562106
India
HDPE containers of 60's Blisters - 10'sTentatively Approved 5/12/2010

Approved 10/28/2016
110ANDA 090788Didanosine125mg / 200mg / 250mg / 400mgDelayed - release CapsulesMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited, F-4 & F-12, Malegaon MIDC Sinnar Nashik-422 113, Maharashtra
India
All four of the strengths will be packaged in HDPE bottles in 30's and 500'sTentatively Approved 4/8/2010
109ANDA 090636Tenofovir Disoproxil Fumarate300mgTabletsHetero Labs Limited Unit III
(formerly Hetero Drugs Limited)
Hetero Labs Limited, Unit III 22-110 Industrial development Area Jeedimetla, Hyderabad - 500 055 Andhra Pradesh
India
HDPE Bottles, 30's, 60's 100's 500's 1000'sTentatively Approved  4/2/2010
108NDA 22299Nevirapine50mgTablet for Oral SuspensionAurobindo Pharma LimitedAurobindo Pharma Limited
Survey No. 313 and 314, Bachupally Quthubullapur Mandal, Hyderabad, Andhra Pradesh India - 500 072
India
HDPE bottles containing 30 or 180 tablets and LDPE bags of 5000 tablets for bulk shipmentTentatively Approved 2/24/2010
107NDA 22420Efavirenz200mgTabletsStrides Arcolab LimitedStrides Arcolab Limited 36/7, Suragajakkanahalli, Indlavadi cross, Anekal Taluk Bangalore – 562106
India
HDPE bottles of 90 tabletsTentatively Approved 2/12/2010
106NDA 22464Lamivudine, Nevirapine, and Zidovudine150mg / 200mg and 300mgTabletsStrides Arcolab LimitedStrides Arcolab Limited 36/7, Suragajakkanahalli, Indlavadi cross, Anekal Taluk Bangalore – 562106
India
HDPE bottles of 60 tabletsTentatively Approved 12/22/09
105NDA 22461Efavirenz50mg, 100mg, and 200mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited,
F-4 & F-12, Malegaon MIDC, Sinnar Nashik-422 113, Maharashtra
India
HDPE bottles (protected with desiccant and an induction seal) containing 30 or 90 tablets, LDPE bags for bulk shipmentTentatively Approved  11/24/09
104ANDA 090371Lopinavir / Ritonavir200mg / 50mgTabletsCipla LimitedCipla Limited A-42, MIDC, Patagonia, Dist: Raged, Maharashtra
India
HDPE Bottles 120 tablets Blister Pack 10 tabletsTentatively Approved 11/20/09
103NDA 22459Lamivudine and Tenofovir disoproxil fumarate300mg / 300mgTabletsHetero Labs Limited Unit III
(formerly Hetero Drugs Limited)
Hetero Labs Limited, Unit-III, 22-110, Industrial Development Area, Jeedimetla, Hyderabad -500 055 Andhra Pradesh
India
HDPE containers of 30, 60 and 100 tabs fitted with child-resistant caps with pulp liner, filler and desiccant (silica gel)
HDPE containers of 500 tabs fitted with continuous thread plastic caps with pulp liner, filler and desiccant (silica gel)
Tentatively Approved 11/05/09
102NDA 22142Efavirenz / lamivudine / tenofovir disoproxil fumarate600 mg / 300 mg / 300 mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited,
Plot # F/4,F/12 Malegaon M.I.D.C., Sinnar, Nashik District Maharashtra State India - 422113
India
HDPE bottles 30's or 100'sTentatively Approved 09/03/09
101ANDA 090437Efavirenz / Emtricitabine / Tenofovir Disoproxil Fumarate600 mg / 200 mg / 300 mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited, Plot # F-4 & F-12 Malegaon MIDC Sinnar, Nashik 422 113 Maharashtra
 India
HDPE Bottles 30's and 100'sTentatively Approved 08/12/09
100ANDA 090457Lamivudine150mg / 300 mgTabletsStrides Arcolab LimitedStrides Arcolab Limited S-No, 36/7 Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore 562 106
India
HDPE Bottles with LDPE Caps 30's and 60'sTentatively Approved 08/06/09
099ANDA 090155Efavirenz200 mgCapsulesCipla LimitedCipla Limited L-147 Verna Industrial Estate Goa -403 722 
India
HDPE Bottles 90's HDPE Bottles 1000'sTentatively Approved 08/03/09
098NDA 22296Lamivudine and Zidovudine30 mg / 60 mgTabletsAurobindo Pharma LimitedAurobindo Pharma Limited Survey No. 313 and 314, Bachupally Quthubullapur Mandal, Hyderabad, Andhra Pradesh India - 500 072
India
HDPE containers of 60 and 1000 tablets PVC / PVdC with aluminun foil blister packs of 10 LDPE bags of 10,000 for bulk shipment (repacking with 6 months)Tentatively Approved 07/23/09
097NDA 22294Zidovudine60 mgTabletsAurobindo Pharma LimitedAurobindo Pharma Limited Survey No. 313 and 314, Bachupally Quthubullapur Mandal, Hyderabad, Andhra Pradesh India - 500 072
India
HDPE containers of 60 and 1000 tablets
PVC/Aluminun blister packs of 10
LDPE bags of 15,000 for bulk shipment (repacking with 6 months)
Approved 07/23/09


Status: Withdrawn
Effective 8/7/13
096NDA 22342Stavudine, Lamivudine, and Nevirapine40mg / 150mg / 200mg
&
30mg / 150mg / 200mg
TabletsEmcure Pharmaceuticals LimitedEmcure Pharmaceuticals Ltd P-2, I.T.B.T. Park MIDC, Hinjwadi, Pune 411 057
India
HDPE containers of 60 tablets fitted with child-resistant closures and induction sealsTentatively Approved 07/16/09
095ANDA 090309Abacavir Sulfate / Lamivudine / Zidovudine300 mg / 150 mg / 300 mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited,
Malegaon M.I.D.C. Shinnar, Nashik-422113 Maharashtra State
India
HDPE Bottles 60'sTentatively Approved 07/15/09
094ANDA 078545 (number for 40 & 94)Lamividune300mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited, Plot #F/4, F/12, Malegaon MIDC, Sinnar, Nashik District PIN – 422 103, Maharashtra State
India
HDPE bottles 60's Blisters'10'sTentatively Approved 06/22/09
 
093ANDA 090679Lamivudine / Zidovudine150mg / 300mgTabletsMacleods Pharmaceuticals LimitedMacleods Pharmaceuticals Limited Plot No. 25 – 27, Survey No. 366, Premier Industrial Estate, Kachigam, Daman – 396210
India
HDPE Bottles 60's Blister Packs 6x10's Preprinted 25 micron Aluminium foil coated with 6-8 gsm Heat Seal Laquer

Blister Packs 12 x10's White Opaque 250 microns PVC coated with 90 gsm PVdC (Width-182 mm)
Tentatively Approved 05/29/09
092NDA 22356Lamivudine / Zidovudine Tablets Co - packaged with Nevirapine Tablets150 mg / 300mg co-packaged with 200mgTabletsHetero Labs Limited Unit III
(formerly Hetero Drugs Limited)
Hetero Labs Limited Unit III 22-110, I.D.A., Jeedimetla Hyderabad – 500055
India
PVC / Alu and PVC / PVDC blister packs with 10 doses on one blister sheet and 6 sheets included in the cartonTentatively Approved 05/07/09
091ANDA 078800Tenofovir Disoproxil Furmarate300mgTabletsCipla LimitedCipla Limited
Verna Industrial Estate Verna Salcette Goa 403 722
India
30's HDPE bottles w/ CRC closure and 1000's HDPE Bottles Screw CapTentatively Approved 04/29/09
090ANDA 090688Nevirapine200mgTabletsMacleod’s Pharmaceuticals LimitedMacleod’s Pharmaceuticals Limited, Plot No. 25 – 27, Survey No. 366, Premier Industrial Estate, Kachigam, Daman – 396210
India
HDPE bottle of 60 tablets
Blister 6x10
Blister 12x10
Tentatively Approved  03/31/09
089ANDA 090513Emtricitabine and Tenofovir Disoproxil Fumarate200mg / 300mgTabletsAurobindo Pharma LimitedAurobindo Pharma Limited (Unit - III) Survey No. 313 & 314, Bachupally, Quthubullapur Mandal Hyderabad, Andhra Pradesh - 500 072
India
HDPE 30’s in CRCTentatively Approved 03/30/09
088ANDA 090519Abacavir Sulfate and Lamivudine600mg / 300mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited, F-4 & F-12, Malegaon MIDC, Sinnar Nashik-422 113, Maharashtra
India
HDPE Bottles with 30’sTentatively Approved 03/30/09
087ANDA 090049Emtricitabine and Tenofovir Disoproxil Fumarate200mg / 300mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited, Plot # F-4 & F-12 Malegaon MIDC, Sinnar, Nashik-422 113, Maharashtra
India
Packaged in 30's, 100's HDPE bottles and - Aluminum Foil and Laminate - Unit Dose -10'sTentatively Approved 03/30/09
086NDA 22347Stavudine and Lamivudine30mg / 150mg and 40mg / 150mgTabletsPharmacare LimitedStrides Arcolab Limited S-No, 36/7 Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore 562 106
India
HDPE fitted with tear-off LDPE caps 60'sTentatively Approved 03/18/09
085ANDA 090433Lamivudine150mgTabletsAlkem Laboratories LimitedAlkem Laboratories Limited 167, Mahatma Gandhi Udyog Nagar Amaliya, Daman- 396 210 (UT)
India
60 count HDPE bottles with CRC closuresTentatively Approved 03/16/09
084ANDA 090471Lopinavir / Ritonavir100mg / 25mg and 200mg / 50mgTabletsAurobindo Pharma LimitedAurobindo Pharma Limited Unit III Survey No. 313 and 314 Bachupally Quthubullapur Mandal, Hyderabad Andhra Pradesh, India 500-072
India
100 mg / 25 mg strength available in HDPE Bottles of 60's and Blister packs of 10's
200 mg / 50 mg strength available in HDPE Bottles of 120's and Blister packs of 10's
Tentatively Approved 03/10/09
083ANDA 079074Lopinavir / Ritonavir200mg / 50mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited, F-4 and F-12
Malegaon MIDC
Sinnar, Nashik-422 113
Maharashta
India
HDPE with CRC closure 120's
HDPE with screw cap 120's
Blister Packs of 6's
Tentatively Approved 03/10/09
082NDA 22346Stavudine Lamivudine + Nevirapine30mg / 150mg / 200mg and 40mg / 150mg / 200mgTabletsPharmacare LimitedStrides Arcolab Limited S-No, 36 / 7 Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore 562 106
India
HDPE bottles containing 60 tabletsTentatively Approved  2/27/09
081ANDA 090647Tenofovir Disoproxil Fumarate300mgTabletsAurobindo Pharma LimitedAurobindo Pharma Limited (Unit - III)
Survey No. 313 & 314, Bachupally,
Quthubullapur Mandal
Hyderabad, Andhra Pradesh
Zip Code: 500 072, India
CFN Number: 3004021229
India
Packaging: 30 Tablets, HDPE BottlesTentatively Approved 2/18/09
080ANDA 090488Emtricitabine200mgCapsulesMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited, Plot # F-4 & F-12 Malegaon MIDC, Sinnar, Nashik-422 113, Maharashtra
India
HDPE bottles of 30s and 100s and unit dose blister packs of 20(2X10) and 30 (3X10)Tentatively Approved 12/23/08
079NDA 22295Abacavir Sulfate + Lamivudine60mg / 30mgTabletsAurobindo Pharma LimitedAurobindo Pharma Limited Survey No. 313 and 314, Bachupally Quthubullapur Mandal Hyderabad, Andhra Pradesh India - 500 072
India
HDPE Container – 30’s Count and 60’s Count Blister Pack – 100 Unit-of-use Tablets (10 x 10s)Tentatively Approved 12/19/08
078NDA 22297Efavirenz100mgTabletsAurobindo Pharma LimitedAurobindo Pharma Limited
Survey No. 313 and 314, Bachupally
Quthubullapur Mandal
Hyderabad, Andhra Pradesh
India - 500 072
India
HDPE Container – 30’s Count and 500’s Count
Blister Pack – 10 x 10 Unit dose Tablets (Carton of 100 Tablets)
 
Tentatively Approved 12/12/08

Status: Withdrawn
Effective 8/7/13
077NDA 22061Lamivudine + Nevirapine + Zidovudine150mg / 200mg / 300mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited,
Plot # F/4, F/12, Malegaon M.I.D.C., Sinnar, Nashik District, Maharashtra State
India
Bottles of 60 Tablets, Unit-dose Blisters of 10's countTentatively Approved 10/21/08
076ANDA 090198Lamivudine150mg and 300mgTabletsMacleods Pharmaceuticals LimitedMacleods Pharmaceuticals Limited,
Plot No. 25 – 27, Survey No. 366,
Premier Industrial Estate, Kachigam,
Daman – 396210
India
150 mg tablets: HDPE Bottles 60's
150 mg tablets, blisters: 6x10's
300 mg tablets: HDPE Bottles 30's
Tentatively Approved 10/7/08
075ANDA 090094Didanosine125mg, 200mg, 250mg, 400mgDelayed - release CapsulesAurobindo Pharma Limited (Unit - III)
 
Aurobindo Pharma Limited (Unit - III)
Survey No. 313 & 314, Bachupally, Quthubullapur Mandal
Hyderabad, Andhra Pradesh, India Zip Code: 500 072
India
 
125 mg
14 Count Blisters 30 Count HDPE Bottles with CRC 500 Count HDPE Bottles non-CRC
200 mg
10 Count Blisters 30 Count HDPE Bottles with CRC 500 Count HDPE Bottles non-CRC
250 mg
10 Count Blisters 30 Count HDPE Bottles with CRC 500 Count HDPE Bottles non-CRC
400 mg
5 Count Blisters 30 Count HDPE Bottles with CRC 500 Count HDPE Bottles non-CRC
Approved 9/24/08
074NDA 22293Abacavir Sulfate60mgTabletsAurobindo Pharma LimitedAurobindo Pharma Limited
Survey No. 313 and 314, Bachupally
Quthubullapur Mandal
Hyderabad, Andhra Pradesh
India - 500 072
India
HDPE Container – 60’s Count and 1000’s Count
Blister Pack – 10 x 10 Unit dose Tablets (Carton of 100 Tablets)
Tentatively Approved 9/12/08

Status: Withdrawn
Effective 8/7/13
073NDA 22141Lamivudine + Tenofovir Disoproxil Fumarate300mg / 300mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited,
Plot # F-4/F-12 ,
Malegaon MIDC, Sinnar,
Nashik-422 103,
Maharashtra
India
30’s HDPE bottle pack
100’s HDPE bottle pack
Tentatively Approved 9/12/08
072 ANDA 090159Abacavir Sulfate + Lamivudine600mg / 300mgTabletsAurobindo Pharma LimitedAurobindo Pharma Limited (Unit - III) Survey No. 313 & 314, Bachupally, Quthubullapur Mandal Hyderabad, Andhra Pradesh - 500 072
India
30's HDPE Bottles 10's BlistersTentatively Approved 9/03/08
071ANDA 077981Zidovudine50mg / 5mLOral solutionCipla LimitedCipla Limited L-139 to L-146 Verna Industrial Estate Goa- 403 722 IndiaHDPE bottles with CRCs-100 mL and 240 mL Approved 6/26/08
070NDA 22167Lamivudine + Stavudine60mg / 12mg and 30mg / 6mgTablets for Oral SuspensionCipla LimitedCipla Limited, L-139 to L-146, Verna Industrial Estate, Goa – 403 722
India
30 tabs / bottle, 60 tabs  / bottle, 1000 tabs / bottle & unit dose boxes of 14 tabletsTentatively Approved 6/19/08
069ANDA 078864Nevirapine200mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited,
F-4 F-12 Malegaon MIDC, Sinnar
Nashik-422 113
Maharashtra
India
HDPE bottles of 60s
PVC Blister Packs of 10s
Tentatively Approved 5/15/08

Approved 05/22/12
068ANDA 079188Emtricitabine200mgCapsulesAurobindo Pharma LimitedAurobindo Pharma Limited (Unit III)
Survey No. 313 & 314
Bachupally, Quthbullapur Mandal,
Hyderabad, Andra Pradesh
Zip Code 500072
India
HDPE Bottles of 30's and 500's
Clear PVC Blister Packs of 10's
Tentatively Approved 5/09/08
067ANDA 090092Zidovudine300mgTabletsHetero Labs Limited Unit III
(formerly Hetero Drugs Limited)
Hetero Labs Limited, Unit-III,
22 - 110, Industrial development Area,
Jeedimetla, Hyderabad -500 055
Andhra Pradesh
India
HDPE Bottles 60's and 500'sApproved 4/25/08
066ANDA 079124Lamividine + Zidovudine150mg / 300mgTabletsHetero Labs Limited Unit III
(formerly Hetero Drugs Limited)
Hetero Labs Limited, Unit-III,
22 - 110, Industrial development Area
Jeedimetla, Hyderabad -500 055
Andhra Pradesh
India 
HDPE Bottles, 60's and 500'sTentatively Approved 4/25/08
065NDA 22177Lamivudine / Stavudine / Nevirapine150mg / 30mg / 200mgTabletsStrides Arcolab LimitedStrides Arcolab Limited S-No, 36/7 Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore 562 106
India
HDPE bottles containing 60 tabletsTentatively Approved 3/20/08
064NDA 21837Lamivudine / Stavudine / Nevirapine150mg / 40mg / 200mgTabletsStrides Arcolab LimitedStrides Arcolab Limited S-No, 36/7 Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore 562 106
India
HDPE bottles containing 60 tabletsTentatively Approved 3/20/08
063ANDA 078886Efavirenz600mgTabletsHetero Labs Limited Unit III
(formerly Hetero Drugs Limited)
Hetero Labs Limited, Unit III
22-110 Industrial Development Area
Jeedimetla, Hyderabad 500 055
Andhra Pradesh
India
30's and 250's HDPE BottlesTentatively Approved 02/29/08
062ANDA 078957Stavudine15mg / 20mg / 30mg / 40mgCapsulesHetero Labs Limited Unit III
(formerly Hetero Drugs Limited)
Hetero Labs Limited, Unit III
22-110 Industrial Development Area
Jeedimetla, Hyderabad 500 055
Andhra Pradesh
India
HDPE bottles of 60s (All strengths), HDPE bottles of 100s (All strengths), HDPE bottles of 500s (30mg and 40mg), HDPE bottles of 1000s (15mg and 20mg)Tentatively Approved 02/28/08

Approved
12/29/08
061ANDA 078922Zidovudine300mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited) 
Mylan Laboratories Limited, F-4 & F-12, Malegaon MIDC, Sinnar
Nashik-422 113, Maharashtra
India
60's HDPE bottles
10's blister pack
Approved 02/14/08
060ANDA 078785Atazanavir Sulfate100mg / 150mg  / 200mgCapsulesEmcure Pharmaceuticals LimitedEmcure Pharmaceuticals Limited
Plot No. P-2, I.T-B.T. Park, Phase II, MIDC
Hinjwadi, Pune – 411 057
India
100 mg Capsules Bottles of 60 Capsules: 60-cc white HDPE 150 mg & 200 mg Bottles of 60 Capsules: 100-cc white opaque HDPE bottle
Foil Blister Packs of 6 Capsules (100 mg, 150 mg, 200 mg Capsules): with 10x6 blisters per cartoon
Tentatively Approved 02/04/08
059ANDA 078850Lamivudine150mg / 300mgTabletsHetero Labs Limited Unit III
(formerly Hetero Drugs Limited)
Hetero Labs Ltd. Unit III
22-110 Industrial Development Area
Jeedimetla, Hyderabad 500 055,Andhra Pradesh
India
HDPE bottles of 60s (150
mg: 60 cc), 30s (300 mg: 60 cc) and 600s (150 mg: 300cc; 300 mg: 500 cc)
Tentatively Approved 01/29/08
058ANDA 078958Efavirenz600mgTabletsEmcure Pharmaceuticals LimitedEmcure Pharmaceuticals Limited Plot No. P-2, I.T.Park, Phase II, MIDC Hinjwadi, Pune – 411 057
India
Coated tablets are packaged into 30 and 60 count HDPE bottles and 10 count blister packsTentatively Approved 12/20/2007
057ANDA 078587Stavudine40mgCapsulesEmcure Pharmaceuticals LimitedEmcure Pharmaceuticals Limited
Plot P-2, IPBT Park Phase II
Hinjwadi, Pune, 411 057, Maharashtra
India
HDPE Bottles - 60's
Blister Packs - 14's
Tentatively Approved 12/12/07
056ANDA 079071Tenofovir Disoproxil Fumarate300mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited) 
Mylan Laboratories Limited,
Malegaon M.I.D.C. Shinnar, Nashik - 422113
Maharashta State
India
30 ct CRC HDPE Bottles
100 ct non-CRC HDPE Bottles
Blister Packs of 20's
(2 x 10)
Tentatively Approved 11/30/07
055ANDA 079079Lamivudine + Zidovudine150mg / 300mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited)  
Mylan Laboratories Limited, F-4 & F-12, Malegaon MIDC, Sinnar, Nashik-422 113, Maharashtra
India
Packaging:
Bottles of 60's HDPE Blisters of 10:
Lidding Foil: 25 micron Alumninum foil
Forming Foil: 250 micron PVC film coated with 40 GSM PVdC
Tentatively Approved 11/29/07
054NDA 22085Lamivudine + Stavudine150mg / 40mg and 150mg / 30mgTabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited) 
Mylan Laboratories Limited, Plot # F/4,F/12
Malegaon M.I.D.C., Sinnar
Nashik District
Maharashtra State
India - 422113
India
HDPE bottles of 60 Blister packs of 10
LDPE bags of 2500
Tentatively Approved 11/02/07
053ANDA 078030Stavudine1mg/mLOral SolutionCipla Limited

 
Cipla Limited
M-61 to M-63
Verna Industrial Estate
Verna, Salcette
Goa – 403 722
India
HDPE bottles 240mlTentatively Approved 10/29/07

Approved 03/20/09
052ANDA 078887Nevirapine200mgTabletsEmcure Pharmaceuticals LimitedEmcure Pharmaceuticals Limited
Plot No. P-2 I.T-B.T. Park, Phase II, MIDC Hinjwadi, Pune, 411 057
India
60's HDPE bottles
10's Blisters
Tentatively Approved 09/28/07
051NDA 21972Lamivudine + Stavudine + Nevirapine 30mg / 6mg / 50mg
and
60mg / 12mg / 100mg
Tablets for Oral SuspensionCipla LimitedCipla Limited,
L-139 to L-146, Verna Industrial Estate, Goa, 403 722
India
HDPE bottles of 60 tablets with child resistant caps
and
HDPE bottles of 1000
Tentatively Approved 08/13/07
050ANDA 078584Nevirapine200mgTabletsHetero Labs Limited Unit III
(formerly Hetero Drugs Limited)
Hetero Labs Limited, Unit III
22-110, Industrial Development Area
Jeedimetla, Hyderabad - 500 055
Andhra Pradesh
India
HDPE bottles:
60's and 500's
(also tested 100's and 1000's)
 
Tentatively Approved 08/13/07

Approved 05/22/12
049ANDA 078929Lamivudine + Zidovudine150mg / 300mgTabletsEmcure Pharmaceuticals LimitedManufacturing Address
Emcure Pharmaceuticals Limited
Plot No. P-2, I.T- B.T. Park, Phase II, MIDC,
Hinjwadi, Pune –411 057
India
60's HDPE bottles
10's Blisters
Tentatively Approved 08/08/07
048ANDA 078883 Efavirenz600mg
 
TabletsMylan Laboratories Limited
(formerly Matrix Laboratories Limited) 
Mylan Laboratories Limited,
F-4 & F-12, Malegaon MIDC, Sinnar
Nashik-422 113, Maharashtra
India
HDPE Bottles of 30
Blister packs of 10
Tentatively Approved 07/12/07
 
047ANDA 078644Nevirapine200mgTabletsHuahai US Inc.Zhejiang Huahai Pharmaceutical Co. Ltd.
Xunqiao, Linhai;
Zhejiang 317024
China
Packaging:
HDPE bottles of 60
Tentatively Approved 07/10/07

Approved 05/22/12
046NDA 22097Stavudine / Lamivudine Co-packaged with Efavirenz40mg / 150mg co-packaged with 600mgtabletsStrides Arcolab LimitedStrides Arcolab Limited S-No, 36/7, Suragajakkanahalli
Indlavadi cross
Anekal Taluk
Bangalore-562106
India
HDPE bottles 85ml & 50ml with tear-off secured strip capTentatively Approved
06/01/07
045NDA 22096Lamivudine / Zidovudine co-packaged with Efavirenz150mg / 300mg co-packaged with Efavirenz Tablets, 600 mgTabletsStrides Arcolab LimitedStrides Arcolab Limited S-No, 36/7, Suragajakkanahalli
Indlavadi cross
Anekal Taluk
Bangalore-562106
India
HDPE bottles 85ml & 50ml with tear-off secured strip cap
 
Tentatively Approved
06/01/07
044 ANDA 078349Zidovudine100mgCapsulesCipla LimitedCipla Limited L138-147 L150 s103-105 Verna, Salcette, GOA 403 722
India
HDPE Bottles 100´s and 1000´sApproved
05/23/07
043ANDA 078775Stavudine30mg / 40mgCapsulesMylan Laboratories Limited
(formerly Matrix Laboratories Limited) 
Mylan Laboratories Limited,
Contact Person: Pramod K. Singh
Plot # F/4, F/12
Sinnar, Nashik District
Maharashtra State
India
HDPE Bottles 60's
Blister Packs, 10's
Tentatively Approved
04/23/07

Approved 01/05/09
042ANDA 078742Abacavir Sulfate300mgTabletMylan Laboratories Limited
(formerly Matrix Laboratories Limited) 
Mylan Laboratories Limited,
Plot #F/4, F/12, Malegaon MIDC
Sinnar, Nashik District, PIN 422 103 Maharashtra
India
HDPE Bottles, 60's
Blister Packs, 10's
Tentatively Approved
04/05/07
041ANDA 078509Efavirenz600mgTabletStrides Arcolab LimitedStrides Arcolab Limited 36/7, Suragajakkanahalli
Indlavadi Cross,
Anekal Taluk
Bangalore, India 562106
India
HDPE bottles of 30Tentatively Approved
03/26/07
040ANDA 078545 (number for 40 & 94)Lamivudine300mgTabletMylan Laboratories Limited
(formerly Matrix Laboratories Limited) 
Mylan Laboratories Limited, Plot #F/4, F/12, Malegaon MIDC, Sinnar, Nashik District
PIN – 422 103, Maharashtra State
India
Bottles of 60 - HDPE
Blister Pack's - 10's
Tentatively Approved
03/19/07
039NDA 21854Stavudine / Lamivudine Co-packaged with Nevirapine40mg / 150mg co-packaged with 200mgTabletStrides Arcolab LimitedStrides Arcolab Limited 36/7, Suragajakkanahalli
Indlavadi Cross
Anekal Taluk
Bangalore, India 560106
India
60 count of tablets-HDPE bottles with snap-on capTentatively Approved
03/13/07
038NDA 21838Stavudine + Lamivudine + Nevirapine40mg / 150mg / 200mgTabletStrides Arcolab LimitedStrides Arcolab Limited 36/7, Suragajakkanahalli
Indlavadi Cross
Anekal Taluk
Bangalore, India 562106
India
60 count of Lamivudine / Stavudine tablets-HDPE bottles with LDPE snap-on cap
60 count of Nevirapine tablets -- HDPE bottles with LDPE snap - on cap
Tentatively Approved
03/13/07
037NDA 21988Lamivudine / Zidovudine Co-packaged with Nevirapine
 
150mg / 300mg co-packaged with 200mgTabletStrides Arcolab LimitedStrides Arcolab Limited 36/7 Suragajakkanahalli
Indlavadi Cross
Anekal Taluk
Bangalore, India 560106
India
HDPE bottles 60 + 60Tentatively Approved
03/02/07
036NDA 21971Lamivudine + Zidovudine + Nevirapine150mg / 300mg / 200mgTabletCipla LimitedCipla Limited,
L-139 to L-146, Verna Industrial Estate, Goa, 403 722
India
HDPE bottles with child resistant closure / 30 count and 60 count
HDPE bottles with screw cap closure / 30 count, 60 count and 500 count
Tentatively Approved
01/31/07
035NDA 21974Lamivudine + Stavudine150mg / 30mg or 40mgTabletCipla LimitedCipla Limited,
L-139 to L-146, Verna Industrial Estate, Goa, 403 722
India
HDPE bottle with child resistant closure / 30 count and HDPE bottle with non-child resistant closure / 1000 count
 
Tentatively Approved
01/19/07

Status: Withdrawn Effective 03/11/16
034ANDA 078064Efavirenz50mg / 100mg / 200mgCapsulesAurobindo Pharma LimitedAurobindo Pharma Limited Unit III, Survey No. 313 &314 Bachupally, Quthubullapur Mandal Hyderabad, Andhra Pradesh India 500 072
India
HDPE Bottles of 30´s (50 mg, 100 mg and 200 mg) and 90´s (200 mg)

PVC / Aclar Film Blister packs of 3 x 10s (50 mg, 100 mg and 200 mg) and 9 x 10s (200 mg)
Tentatively Approved
12/19/06
033NDA 21-969Lamivudine + Stavudine + Nevirapine150mg / 40mg / 200mg
and
150mg / 30mg / 200mg
 
TabletCipla LimitedCipla Limited
L-139 to 146 Verna Industrial Estate
Verna Goa 403 722
India
HDPE Bottle 30, 60, & 1000Tentatively Approved
11/17/06

Status: Withdrawn Effective 03/15/16
032ANDA 078119Abacavir Sulfate300mg (base)TabletCipla LimitedCipla Limited, Manufacturing Division, Plot A-23/1/2 India, Patalganga Industrial Area
District – Raigad, Maharashtra
India
HDPE bottle 60'sTentatively Approved
11/06/06
031ANDA 078112Didanosine10mg/mLOral SolutionAurobindo Pharma, LimitedAurobindo Pharma Ltd, Unit III, Survey 313 & 314, Bachupally, Quthubullapur Mandal, Hyderabad, Andhra Pradesh, India 500 072
India
2 g (4 oz HDPE bottles)
2 g (4 oz Glass bottles)
4 g (8 oz HDPE bottles)
4 g (8 oz Glass bottles)
Tentatively Approved
10/05/06

Approved
03/08/07
030ANDA 077411Lamivudine + Zidovudine150mg / 300mgTabletsCipla LimitedCipla Limited
L-139 to L-146
Verna Industrial Estate
Goa-403 722
India
Blisters 10's (PVC / PVDC film & Plain blister foil)

HDPE Bottles 60's

HDPE Bottles 1000's
Tentatively Approved
09/13/06
029ANDA 078256Stavudine30mg and 40mgCapsulesStrides Arcolab LimitedStrides Arcolab Limited 36/7 Suragajakkanahalli Indlavadi cross, Anekal Taluk Bangalore - 560106
India
HDPE Bottles of 60'sTentatively Approved
08/28/06
028NDA 22-018Lamivudine + Zidovudine150mg / 300mgTabletsPharmacare LimitedPharmacare Limited, 7 Fairclough Road, Korsten, Port Elizabeth, 6020
Republic of South Africa
PVC / PE / PVDC Film / Aluminurm Foil blister cards (triplex blisters)
Each Blister Card Contains: 10
Each Carton Contains: 60
Tentatively Approved
08/23/06
027ANDA 078195Nevirapine200mgTabletsStrides Arcolabs LimitedStrides Arcolabs Limited 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bangalore -560106
India
HDPE bottle 60'sTentatively Approved
08/11/06

Approved 05/22/12
026NDA 21-944Lamivudine / Zidovudine Co-packaged with Abacavir150mg / 300mg co-packaged with 300mgTabletsAurbindo Pharma LimitedAurobindo Pharma Ltd, Unit III, Survey 313 & 314, Bachupally, Quthubullapur Mandal, Hyderbad, Andhra Pradesh
India
PVC / PVdC / Aluminum Foil Each Blister Card Contains: 10 + 10 Each Carton Contains: 60 + 60Tentatively Approved
07/26/06
025ANDA 077275Didanosine100mg / 150mg / 200mgTablet  /  Chewable /  Dispersible /  BufferredAurbindo Pharma LimitedAurobindo Pharma Limited, Unit - III Survey No.: 13 Gaddapotharam IDA-Dazipally Jinnaram, Medak District Andhara Pradesh – 502 319
India
HDPE bottles 60Tentatively Approved
07/10/06

Approved 08/14/12
024NDA 21939Lamivudine + Zidovudine + Nevirapine150mg / 300mg / 200mgTabletsAurobindo Pharma LimitedAurobindo Pharma Limited, Unit III
Survey No. 313 & 314, Bachupally,
Quthubullapur Mandal Hyderabad,
Andhra Pradesh, India - 500 072
India
HDPE bottles 60

Blister cards 10
PVC / PVDC / Aluminum
Tentatively Approved
06/30/06
023ANDA 077672 (number for 8 & 23)Stavudine15mg / 20mgCapsulesAurobindo Pharma LimitedAurobindo Pharma Limited, Unit III
Survey No. 313 & 314, Bachupally,
Quthubullapur Mandal Hyderabad,
Andhra Pradesh, India - 500 072,
India
HDPE Bottles 60'sTentatively Approved
06/27/06
022ANDA 077950Abacavir Sulfate20mg/mLOral SolutionAurobindo Pharma LimitedAurobindo Pharma Limited, Unit III
Survey No. 313 & 314, Bachupally,
Quthubullapur Mandal Hyderabad,
Andhra Pradesh, India - 500 072
India
HDPE Bottles 240 mLTentatively Approved
06/27/06
021ANDA 077980Lamivudine10mg/mLOral SolutionCipla LimitedCipla Limited L-139 to L-146, Verna Industrial Estate, Goa -- 403 722
India
HDPE bottles 100 mL and 240 mLTentatively Approved
06/22/06
020ANDA 077916 Efavirenz600mgTabletsCipla LimitedCipla Limited L-139 to L-146, Verna Industrial Estate, Goa -- 403 722
India
HDPE Bottles 30 and 500Tentatively Approved
05/24/06
019ANDA 077956Nevirapine200mgTabletsCipla LimitedCipla Limited L-139 to L-146, Verna Industrial Estate, Goa -- 403 722
India
HDPE Bottles 60 and 1000Tentatively Approved
05/19/06

Approved 05/22/12
018ANDA 077844Abacavir Sulfate300mgTabletsAurobindo Pharma LimitedAurobindo Pharma Limited Unit III, Survey No 313 Bachyupally, Quthubullapur Mandal Hyderabad, Andhra Pradesh India 500 072
India
HDPE bottles 60

Blisters 10
PVC / Plain Aluminium Foil
Tentatively Approved
05/17/06

Approved
12/17/12
017ANDA 078128Zidovudine100 mgCapsuleAurobindo Pharma LimitedAurobindo Pharma Limited, Survey No 313 and 314, Bachupally Quthubullapur Mandal Hyderabad, Anda Pradesh India 500 072
India
HDPE Bottle 100



Blister 10 x 10
Approved
03/27/06
016NDA  21943Lamivudine / Zidovudine Co-packaged with Efavirenz
 
150mg / 300mg co-packaged with 600mgTabletsAurobindo Pharma LimitedAurobindo Pharma Limited
Survey No 313 and 314
Bachupally, Quthubullapur Mandal
Hyderabad, Andhra Pradesh
India, 500 072
India
PVC / PE / ACLAR /
aluminum foil
-------
Blister cards 10 + 5


carton 60 + 30
Tentatively Approved
03/06/06
 
015ANDA 077702Nevirapine50mg / 5mLOral SuspensionAurobindo Pharma LimitedAurobindo Pharma Limited
Survey No. 313 and 314, Bachupally
Quthubullapur Mandal, Hyderabad
Andhra Pradesh, India - 500 072
India
HDPE Bottle 240 mLTentatively Approved
12/29/05

Approved 05/22/12
014ANDA 077774Stavudine
 
1mg/mLOral SolutionAurobindo Pharma Limited
 
Aurobindo Pharma Limited
Survey No. 313 and 314, Bachupally
Quthubullapur, Hyderabad
Andhra Pradesh, India 500 072
India
 
HDPE Bottle 200 mL
 
Tentatively Approved
12/21/05

Approved
12/29/08
013ANDA 077695Lamivudine10mg/mLOral SolutionAurobindo Pharma LimitedAurobindo Pharma Limited
 Unit III Survey No. 313, Bachupally, Quthubullapur Mandal, Hyderabad, Andhra Pradesh, India 500 072
India
HDPE Bottle 240 mLTentatively Approved 11/08/05
012ANDA 077268Zidovudine50mg / 5mLOral SolutionAurobindo Pharma LimitedAurobindo Pharma Limited
 Unit III Survey No. 313, Bachupally, Quthubullapur Mandal, Hyderabad, Andhra Pradesh, India 500 072
India
HDPE Bottles 240 mLTentatively Approved 9/07/05

Approved 9/19/05
011ANDA 077267Zidovudine300mgTabletsAurobindo Pharma LimitedAurobindo Pharma Limited Survey No. 313, Bachupally, Quthubullapur, Hyderabad, Andhra Pradesh, India 500 072
India
HDPE Bottle 60 and Blister 10Tentatively Approved 8/25/05; Approved 9/19/05
010ANDA 077327Zidovudine300mgTabletsRanbaxy Laboratories LimitedRanbaxy laboratories Limited, Paonta Sahib, District Sirmour,Himachal Pradesh 173 025
India
Blister 8 and HDPE Bottle 60Tentatively Approved 7/13/05

Approved 9/19/05

Status: Withdrawn Effective 4/25/2012
009ANDA 077558Lamivudine + Zidovudine150mg / 300mgTabletsAurobindo Pharma LimitedAurobindo Pharma Limited Unit III Survey No. 313, Bachupally, Quthubullapur Mandal, Hyderabad, Andhra Pradesh, India 500 072
India
HDPE Bottle 60 and Blister 10Tentatively Approved 7/07/05
008ANDA 077672 (number for 8 & 23)Stavudine15mg / 20mg / 30mg / 40mgCapsulesAurobindo Pharma LimitedAurobindo Pharma Limited Unit III Survey No. 313 and 314,Bachupally, Quthubullapur Mandal, Hyderabad, Andhra Pradesh, India 500 072
India
HDPE Bottle 60Tentatively Approved 7/01/05

Approved 12/29/08
007ANDA 077673Efavirenz600 mgTabletsAurobindo Pharma LimitedAurobindo Pharma Limited Unit III Survey No. 313, Bachupally, Quthubullapur Mandal, Hyderabad, Andhra Pradesh, India 500 072
India
HDPE Bottle 30 and Blister 10Tentatively Approved 6/24/05
006ANDA 077521Nevirapine200mgTabletsAurobindo Pharma LimitedAurobindo Pharma Limited Unit III Survey No. 313, Bachupally, Quthubullapur Mandal, Hyderabad, Andhra Pradesh, India 500 072
India
HDPE Bottle 60 and Blister 10Tentatively Approved 6/20/05

Approved 05/22/12
005ANDA 077464Lamivudine150mg and 300mgTabletsAurobindo Pharma LimitedAurobindo Pharma Limited Unit III Survey No. 313, Bachupally, Quthubullapur Mandal, Hyderabad, Andhra Pradesh, India 500 072
India
HDPE Bottle 30 (300 mg) and HDPE Bottle 60 (150 mg) and Blister 10Tentatively Approved 6/15/05
004ANDA 077429Nevirapine200mgTabletsRanbaxy Laboratories LimitedRanbaxy Laboratories Limited, Paonta Sahib, District Sirmour,Himachal Pradesh 173 025
India
Blister 10 and HDPE Bottle 60, 1000Tentatively Approved 5/27/05


Status: Withdrawn Effective 1/20/2016
003ANDA 077357Lamivudine  150mgTabletsRanbaxy Laboratories LimitedRanbaxy Laboratories Limited, Paonta Sahib, District Sirmour,Himachal Pradesh 173 025
India
HDPE Bottle 60 and Blister 10Tentatively Approved 5/27/05


Status: Withdrawn Effective 1/20/2016
002NDA 21841Lamivudine / Zidovudine Co-packaged with Nevirapine150mg / 300mg co-packaged with 200mgTabletsPharmacare Limited7 Fairclough Road
Korsten
Port Elizabeth , 6020
Republic of South Africa
Carton containing ten PVC / PE / PVDC Blister cards. Each card contains 6 lamivudine / zidovudine tablets and 6 nevirapine tablets.Tentatively Approved 1/24/05
001ANDA 077167Didanosine200mg, 250mg, 400mgDelayed Release CapsuleBarrBarr Laboratories, Inc. 2 Quaker Rd. Pomona, NY 10970
USA
HDPE Bottle 30Approved 12/03/04

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