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

« Return to Presidential Emergency Plan for AIDS Relief (PEPFAR)

# Application Number Established Name Strength Dosage Form Supplier Manufacturing Site Drug Product Packaging Material and Pack Date of FDA Approval or Tentative Approval
171 NDA 205861 Efavirenz, Lamivudine and Tenofovir disoproxil fumarate 600 mg / 300 mg / 300 mg Tablet Macleods Pharmaceuticals Limited Macleods 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 seal Tentative Approved 8/14/2014
170 NDA 205508 Atazanavir Sulfate and Ritonavir 300 mg / 100 mg Tablets Emcure Pharmaceuticals Limited Emcure 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 closure Tentative Approved 3/17/2014
169 NDA 205355 Lamivudine and Tenofovir Disoproxil Fumarate Tablets, co-packaged with Nevirapine Tablets 300 mg / 300 mg, co-packaged with 200 mg Tablets Hetero Labs Limited Unit III 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) Tentative Approved 3/14/2014
168 ANDA 090958 Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg / 300 mg Tablets Cipla Limited Cipla Limited
L-147 – L147-1 Verna Industrial Estate Verna Goa 403 722 India
HDPE Bottles, 30’s, non-CRC, silica gel bags Tentative Approved 2/26/2014
167 NDA 204914 Lamivudine and Zidovudine 30 mg / 60 mg Tablet for Oral Suspension Mylan 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 desiccant Tentative Approved 2/4/2014
166 ANDA 204806 Atazanavir Sulfate 100 mg / 150 mg / 200 mg / 300 mg Capsules Aurobindo Pharma Limited 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 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
Tentative Approved 1/31/2014
165 NDA 204568 Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate 600 mg / 300 mg /300 mg Tablets Cipla Limited Cipla Limited., Unit II, A-42, MIDC, Patalganga, District Raigad, Maharashtra, India HDPE bottles of 30 count with non child-resistant closure Tentative Approved 12/30/2013
164 ANDA 203053 Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate 600 mg / 200 mg / 300 mg Tablets Hetero Labs Limited Unit V Hetero 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, dessicant Tentative Approved 10/31/2013
163 NDA 204505 Lamivudine and Tenofovir Disoproxil Fumarate Tablets, Co-packaged with Nevirapine Tablets USP 300 mg /300 mg co-packaged with 200 mg Tablets Aurobindo Pharma Limited 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 30-day supply (15 two-day blister cards with a desiccant layer) Tentative Approved 10/18/2013
162 ANDA 091055 Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg / 300 mg 200 mg / 300 mg Tablets Strides Arcolab Limited Strides Arcolab Limited
36/7, Suragajakkanahalli, Indlavadi cross, Anekal Taluk Bangalore – 562106 INDIA
HDPE Bottles - 30's, Screw Cap, Liner, Dessicant Tentative Approved 07/31/2013
161 NDA 22343 Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate 600 mg / 300 mg / 300 mg Tablet Aurobindo Pharma Limited Aurobindo 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 desiccant Tentative Approved 06/26/2013
160 NDA 202529 Lamivudine and Tenofovir disoproxil fumarate 300 mg / 300 mg Tablet Ranbaxy Laboratories Limited Ranbaxy 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 closure Tentative Approved 05/17/2013
159 ANDA 203041 Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate 600 mg / 200 mg / 300 mg Tablet Aurobindo Pharma Limited 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 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
Tentative Approved 04/02/2013
158 NDA 203283 Lamivudine and Tenofovir disoproxil fumarate 300 mg / 300 mg Tablet Macleods Pharmaceuticals Limited Macleods 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 closure Tentative Approved 11/8/2012
157 NDA 204119 Efavirenz, Lamivudine, and Tenofovir disoproxil fumarate 600 mg / 300 mg / 300 mg Tablet Hetero Labs Limited Unit III
(formerly Hetero Drugs Limited)
Hetero Labs Limited Unit III 22-110, IDA, Jeedimetla, Hyderabad – 500 055 HDPE bottles of 30 tablets with desiccant and child resistant closure Tentative Approved 11/8/2012
156 NDA 203076 Lamivudine, Nevirapine and Zidovudine 30 mg / 50 mg/ 60 mg Tablets for Oral Suspension Cipla Limited Cipla 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
Tentative Approved 10/16/2012
155 NDA 202685 Lamivudine, Nevirapine and Zidovudine 30 mg / 50 mg / 60 mg Tablets for Oral Suspension Strides Arcolab Limited Strides 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 caps Tentative Approved 09/21/2012
154 ANDA 201107 Abacavir 20 mg / mL Oral Solution Hetero 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 mL Tentative Approved 07/02/2012
153 ANDA 091203 Lopinavir and Ritonavir 80 mg / 20 mg per mL Oral Solution Cipla 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 mL Tentative Approved 06/29/2012
152 ANDA 202990 Efavirenz 600 mg Tablets Edict Pharmaceuticals Private Limited
 
Edict Pharmaceuticals Private Limited
1/58 Pudupakkam Main Road, Pudupakkam Chennai 603 103, India
HDPE 30's Tentative Approved 06/25/2012
151 ANDA 202301 Efavirenz 600 mg Tablets Micro Labs Limited Micro 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
Tentative Approved 06/20/2012
150 NDA 202814 Lamivudine and Zidovudine 30 mg / 60 mg Tablets for Oral Suspension Cipla Limited Cipla 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)
Tentative Approved 06/15/2012
149 ANDA 200406 Lamivudine 150 mg and 300 mg Tablets Micro Labs Limited Micro 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
Tentative Approved 05/30/2012
148 ANDA 091475 Lamivudine 10 mg / ml Oral Solution Hetero Labs Limited Unit III
(formerly Hetero Drugs Limited)
M/S Hetero Drugs Limited Unit-III 22-110, Industrial Development Area Jeedimetla, Hyderabad - 500 055 HDPE Bottle - 240 ml Tentative Approved 05/29/2012
147 ANDA 091677 Lopinavir and Ritonavir 200 mg /50 mg Tablets Hetero 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)
Tentative Approved 05/23/2012
146 ANDA 203080 Nevirapine 200 mg Tablets Micro Labs Limited Micro 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's Approved 05/22/2012

Approved 05/22/12
145 ANDA 203176 Nevirapine 200 mg Tablets ScieGen Pharmaceuticals, Inc. Sciegen Pharmaceuticals Inc,
20, Davids Drive
Hauppauge, New York 11788
USA
HDPE Bottles 30's and 500's Tentative Approved 04/30/2012

Approved 05/22/12
144 NDA 202212 Nevirapine 50 mg and 100 mg Tablets for Oral Suspension Cipla Limited Cipla 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
Tentative Approved 04/30/2012
143 ANDA 091593 Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate 600 mg / 200 mg / 300 mg Tablets Cipla Limited Cipla Limited
L-147 – L147-1
Verna Industrial Estate,
Verna Goa,
India
HDPE Bottles 30's Tentative Approved 02/27/2012
142 NDA 202589 Lamivudine, Nevirapine, and Zidovudine 150 mg / 200 mg / 300 mg Tablets Macleods Pharmaceuticals Limited Macleods 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 closure Tentative Approved 02/08/2012
141 NDA 202381 Abacavir Sulfate and Lamivudine 60 mg / 30 mg Tablets Mylan 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 desiccant Tentative Approved 01/31/2012
140 ANDA 091144 Abacavir Sulfate and Lamivudine 600 mg (base) / 300 mg Tablets Cipla Limited Cipla Limited A-33, MIDC, Patalganga, Dist: Raigad, Maharashtra, India HDPE bottles 30's, Unit dose blister packs 3 x 10's Tentative Approved 01/31/2012
139 ANDA 0202042 Efavirenz 50 mg / 200 mg Capsules Micro Labs Limited Micro 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 Seal Tentative Approved 01/19/2012
138 ANDA 201806 Emtricitabine / Tenofovir Disoproxyl Fumarate 200 mg / 300 mg Tablets Hetero 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's Tentative Approved 12/22/2011
137 NDA 202157 Lamivudine / Nevirapine / Zidovudine 150 mg / 200 mg / 300 mg Tablets Hetero 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 tablets Tentative Approved 11/18/2011
136 NDA 22282 Atazanavir Sulfate / Ritonavir 300 mg / 100 mg Tablets Mylan 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 desiccant Tentative Approved 11/18/2011
135 ANDA 202058 Zidovudine 300mg Tablets HEC Pharm, Inc. Sunshine Lake Pharma Co. Ltd.
1 Northern Industry Road Song Sham Lake, DongGuan GuangDong Province P. R. China 523808
HDPE Bottles 60's Tentative Approved 10/07/2011
134 NDA 201151 Lamivudine and Zidovudine 30 mg / 60mg Tablets Cipla Limited Cipla 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
Tentative Approved 09/22/2011
133 NDA 202171 Lamivudine / Tenofovir Disoproxil Fumarate Tablets Co-packaged with Nevirapine Tablets 300 mg / 300mg Co-packaged with 200 mg Tablets Mylan 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 packs Tentative Approved 09/08/2011
132 ANDA 091579 Efavirenz 600 mg Tablets Macleods Pharmaceuticals Limited Macleods Pharmaceuticals Limited
Village Theda, Post Office Lodhimajra
Tehsil Nalagarh, District Solan
Himachal Pradesh – 174101
India
HDPE Bottles, 30's Tentative Approved 08/29/2011
131 ANDA 090742 Tenofovir Disoproxil Fumarate 300 mg Tablets Strides Arcolab Limited Strides Arcolab Limited
36/7 Suragajakkanahalli
Indlavadi Cross, Anekal Taluk
Bangalore 562 106, INDIA
HDPE Bottles 30's Tentative Approved 05/25/2011
130 NDA 202007 Abacavir Sulfate and Lamivudine 60 mg / 30 mg Tablets for Oral Suspension Cipla Limited Cipla 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
Tentative Approved 05/12/2011
129 ANDA 091168 Emtricitabine 200 mg Capsules Cipla Limited Cipla Limited
Manufactured Division, Verna Industrial Estate, Salcette, Goa - 403 722, India
HDPE Bottles, 30's and 1000's Tentative Approved 03/29/2011
128 NDA 22547 Abacavir Sulfate 60 mg Tablets for Oral Suspension Cipla Limited Cipla 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 caps Tentative Approved 03/04/2011
127 NDA 200623 Lamivudine and Tenofovir Disoproxil Fumarate 300 mg / 300 mg Tablets Cipla Limited Cipla Limited
D-7, MIDC Industrial Area, Kurkumbh; Dist: Pune 413 802, India
HDPE containers with desiccant and heat-seal containing 30 tablets or 500 tablets Tentative Approved 03/04/2011
126 NDA 200732 Zidovudine 100 mg Tablet Mylan 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 tablets Approved 02/23/2011
125 ANDA 078348 Abacavir Sulfate 20 mg (base) / mL Oral Solution Cipla Limited Cipla Limited
L-139 to L-146 Verna Industrial Estate Goa – 403 722 INDIA
100 mL and 240 mL HDPE bottles Tentative Approval 02/16/2011
124 NDA 22344 Lamivudine and Tenofovir Disoproxil Fumarate 300 mg / 300 mg Tablets Aurobindo Pharma Limited Aurobindo 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)
Tentative Approval 01/07/2011
123 NDA 200748 Lamivudine and Zidovudine 30 mg / 60 mg Tablets Mylan 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 tablets Tentative Approval 1/05/2011
122 NDA 200733 Abacavir Sulfate 60 mg Tablets Mylan 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 tablets Tentative Approval 11/29/2010
121 ANDA 090561 Zidovudine 300 mg Tablets Cipla Limited Cipla Limited Verna Industrial Estate Verna, Salcette, Goa – 403 722, India HDPE Bottles; 60's , 1000's, Blister Pack: 10's Tentative Approval 10/27/2010
120 ANDA 079128 Lamivudine and Zidovudine 150 mg and 300 mg Tablets Strides Arcolab Limited 36/7, Suragajakkanahalli Indlavadi cross Anekal Taluk Bangalore – 562106 India HDPE Bottles 60's Tentative Approval 10/18/2010
119 ANDA 091560 Abacavir Sulfate 300 mg Tablets Hetero 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's Tentative Approval 9/29/2010
118 ANDA 0091611 Atazanavir Sulfate 150 mg and 300 mg Capsules Mylan 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 capsules Tentative Approval 9/15/2010
117 NDA 200244 Lamivudine, Nevirapine, and Stavudine 150 mg / 200 mg / 30 mg Tablet Hetero 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 tablets Tentative Approval 9/10/2010
116 NDA 22537 Lamivudine, Nevirapine, and Stavudine 150 mg / 200 mg / 30 mg Tablet Macleods Pharmaceuticals Limited Macleods 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 tablets Tentative Approval 8/30/2010
115 ANDA 200196 Atazanavir Sulfate 300 mg Capsules Emcure Pharmaceuticals Limited Emcure Pharmaceuticals Limited Plot No. P-1, 2, I.T. - B.T. Park, Phase II, MIDC, Hinjwadi, Pune - 411 057, INDIA 30's HDPE Bottles Tentative Approval 8/19/2010
114 NDA 22541 Lamivudine and Stavudine 150 mg / 30 mg Tablet Macleods Pharmaceuticals Limited Macleods 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 tablets Tentative Approval 8/05/2010
113 NDA 200793 Lamivudine, Nevirapine, and Zidovudine 30mg / 50mg / 60mg Tablet for Oral Suspension Mylan 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) Tentative Approval 7/08/2010
112 NDA 22479 Lamivudine and Stavudine 150mg / 30mg Tablets Hetero 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) Tentative Approval 5/17/2010
111 ANDA 091050 Abacavir Sulfate 300mg Tablets Strides Arcolab Limited Strides Arcolab Ltd. 36/7 Suragajakkanahalli, Indlavadi cross, Anekal Taluk Bangalore - 562106 INDIA HDPE containers of 60's Blisters - 10's Tentative Approval 5/12/2010
110 ANDA 090788 Didanosine 125mg / 200mg / 250mg / 400mg Delayed - release Capsules Mylan 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's Tentative Approval 4/8/2010
109 ANDA 090636 Tenofovir Disoproxil Fumarate 300mg Tablet Hetero 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's Tentative Approval 4/2/2010
108 NDA 22299 Nevirapine 50mg Tablet for Oral Suspension Aurobindo Pharma Limited Aurobindo Pharma Limited
Survey No. 313 and 314, Bachupally Quthubullapur Mandal, Hyderabad, Andhra Pradesh India - 500 072
HDPE bottles containing 30 or 180 tablets and LDPE bags of 5000 tablets for bulk shipment Tentative Approval 2/24/2010
107 NDA 22420 Efavirenz 200mg Tablets Strides Arcolab Limited Strides Arcolab Limited 36/7, Suragajakkanahalli, Indlavadi cross, Anekal Taluk Bangalore – 562106 INDIA HDPE bottles of 90 tablets Tentative Approval 2/12/2010
106 NDA 22464 Lamivudine, Nevirapine, and Zidovudine 150mg / 200mg and 300mg Tablets Strides Arcolab Limited Strides Arcolab Limited 36/7, Suragajakkanahalli, Indlavadi cross, Anekal Taluk Bangalore – 562106 INDIA HDPE bottles of 60 tablets Tentative Approval 12/22/09
105 NDA 22461 Efavirenz 50mg, 100mg, and 200mg Tablets Mylan 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 shipment Tentative Approval 11/24/09
104 ANDA 090371 Lopinavir / Ritonavir 200mg / 50mg Tablets Cipla Limited Cipla Limited A-42, MIDC, Patagonia, Dist: Raged, Maharashtra, India HDPE Bottles 120 tablets Blister Pack 10 tablets Tentative Approval 11/20/09
103 NDA 22459 Lamivudine and Tenofovir disoproxil fumarate 300mg / 300mg Tablets Hetero 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)
Tentative Approval 11/05/09
102 NDA 22142 Efavirenz / lamivudine / tenofovir disoproxil fumarate 600 mg / 300 mg / 300 mg Tablets Mylan 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
HDPE bottles 30's or 100's Tentative Approval 09/03/09
101 ANDA 090437 Efavirenz / Emtricitabine / Tenofovir Disoproxil Fumarate 600 mg / 200 mg / 300 mg Tablets Mylan 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's Tentative Approval 08/12/09
100 ANDA 090457 Lamivudine 150mg / 300 mg Tablets Strides Arcolab Limited Strides Arcolab Limited S-No, 36/7 Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore 562 106, INDIA HDPE Bottles with LDPE Caps 30's and 60's Tentative Approval 08/06/09
99 ANDA 090155 Efavirenz 200 mg Capsules Cipla Limited Cipla Limited L-147 Verna Industrial Estate Goa -403 722 India HDPE Bottles 90's HDPE Bottles 1000's Tentative Approval 08/03/09
98 NDA 22296 Lamivudine and Zidovudine 30 mg / 60 mg Tablets Aurobindo Pharma Limited Aurobindo Pharma Limited Survey No. 313 and 314, Bachupally Quthubullapur Mandal, Hyderabad, Andhra Pradesh India - 500 072 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) Tentative Approval 07/23/09
97 NDA 22294 Zidovudine 60 mg Tablets Aurobindo Pharma Limited Aurobindo Pharma Limited Survey No. 313 and 314, Bachupally Quthubullapur Mandal, Hyderabad, Andhra Pradesh India - 500 072 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
96 NDA 22342 Stavudine, Lamivudine, and Nevirapine 40mg / 150mg / 200mg
&
30mg / 150mg / 200mg
Tablets Emcure Pharmaceuticals Limited Emcure 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 seals Tentative Approval 07/16/09
95 ANDA 090309 Abacavir Sulfate / Lamivudine / Zidovudine 300 mg / 150 mg / 300 mg Tablets Mylan Laboratories Limited
(formerly Matrix Laboratories Limited)
Mylan Laboratories Limited,
Malegaon M.I.D.C. Shinnar, Nashik-422113 Maharashtra State, India
HDPE Bottles 60's Tentative Approval 07/15/09
94 ANDA 078545 (number for 40 & 94) Lamividune 300mg Tablets Mylan 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's Tentative Approval 06/22/09
93 ANDA 090679 Lamivudine / Zidovudine 150mg / 300mg Tablets Macleods Pharmaceuticals Limited Macleods 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)
Tentative Approval 05/29/09
92 NDA 22356 Lamivudine / Zidovudine Tablets Co - packaged with Nevirapine Tablets 150 mg / 300mg co-packaged with 200mg Tablets Hetero 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 carton Tentative Approval 05/07/09
91 ANDA 078800 Tenofovir Disoproxil Furmarate 300mg Tablets Cipla Limited Cipla Limited
Verna Industrial Estate Verna Salcette Goa 403 722, INDIA
30's HDPE bottles w/ CRC closure and 1000's HDPE Bottles Screw Cap Tentative Approval 04/29/09
90 ANDA 090688 Nevirapine 200mg Tablets Macleod’s Pharmaceuticals Limited Macleod’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
Tentative Approval 03/31/09
89 ANDA 090513 Emtricitabine and Tenofovir Disoproxil Fumarate 200mg / 300mg Tablets Aurobindo Pharma Limited Aurobindo Pharma Limited (Unit - III) Survey No. 313 & 314, Bachupally, Quthubullapur Mandal Hyderabad, Andhra Pradesh - 500 072, India HDPE 30’s in CRC Tentative Approval 03/30/09
88 ANDA 090519 Abacavir Sulfate and Lamivudine 600mg / 300mg Tablets Mylan 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’s Tentative Approval 03/30/09
87 ANDA 090049 Emtricitabine and Tenofovir Disoproxil Fumarate 200mg / 300mg Tablets Mylan 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's Tentative Approval 03/30/09
86 NDA 22347 Stavudine and Lamivudine 30mg / 150mg and 40mg / 150mg Tablets Pharmacare Limited Strides Arcolab Limited S-No, 36/7 Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore 562 106, INDIA HDPE fitted with tear-off LDPE caps 60's Tentative Approval 03/18/09
85 ANDA 090433 Lamivudine 150mg Tablets Alkem Laboratories Limited Alkem Laboratories Limited 167, Mahatma Gandhi Udyog Nagar Amaliya, Daman- 396 210 (UT) India 60 count HDPE bottles with CRC closures Tentative Approval 03/16/09
84 ANDA 090471 Lopinavir / Ritonavir 100mg / 25mg and 200mg / 50mg Tablets Aurobindo Pharma Limited Aurobindo Pharma Limited Unit III Survey No. 313 and 314 Bachupally Quthubullapur Mandal, Hyderabad Andhra Pradesh, India 500-072 100 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
Tentative Approval 03/10/09
83 ANDA 079074 Lopinavir / Ritonavir 200mg / 50mg Tablets Mylan 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
Tentative Approval 03/10/09
82 NDA 22346 Stavudine Lamivudine + Nevirapine 30mg / 150mg / 200mg and 40mg / 150mg / 200mg Tablets Pharmacare Limited Strides Arcolab Limited S-No, 36 / 7 Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore 562 106, INDIA HDPE bottles containing 60 tablets Tentative Approval 2/27/09
81 ANDA 090647 Tenofovir Disoproxil Fumarate 300mg Tablets Aurobindo Pharma Limited Aurobindo Pharma Limited (Unit - III)
Survey No. 313 & 314, Bachupally,
Quthubullapur Mandal
Hyderabad, Andhra Pradesh
Zip Code: 500 072, India
CFN Number: 3004021229
Packaging: 30 Tablets, HDPE Bottles Tentative Approval 2/18/09
80 ANDA 090488 Emtricitabine 200mg Capsules Mylan 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) Tentative Approval 12/23/08
79 NDA 22295 Abacavir Sulfate + Lamivudine 60mg / 30mg Tablets Aurobindo Pharma Limited Aurobindo Pharma Limited Survey No. 313 and 314, Bachupally Quthubullapur Mandal Hyderabad, Andhra Pradesh India - 500 072 HDPE Container – 30’s Count and 60’s Count Blister Pack – 100 Unit-of-use Tablets (10 x 10s) Tentative Approval 12/19/08
78 NDA 22297 Efavirenz 100mg Tablets Aurobindo Pharma Limited Aurobindo Pharma Limited
Survey No. 313 and 314, Bachupally
Quthubullapur Mandal
Hyderabad, Andhra Pradesh
India - 500 072
HDPE Container – 30’s Count and 500’s Count
Blister Pack – 10 x 10 Unit dose Tablets (Carton of 100 Tablets)
 
Tentative Approval 12/12/08
77 NDA 22061 Lamivudine + Nevirapine + Zidovudine 150mg / 200mg / 300mg Tablets Mylan 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 count Tentative Approval 10/21/08
76 ANDA 090198 Lamivudine 150mg and 300mg Tablets Macleods Pharmaceuticals Limited Macleods 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
Tentative Approval 10/7/08
75 ANDA 090094 Didanosine 125mg, 200mg, 250mg, 400mg Delayed - release Capsules Aurobindo Pharma Limited (Unit - III)
 
Aurobindo Pharma Limited (Unit - III)
Survey No. 313 & 314, Bachupally, Quthubullapur Mandal
Hyderabad, Andhra Pradesh, India Zip Code: 500 072
 
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
74 NDA 22293 Abacavir Sulfate 60mg Tablet Aurobindo Pharma Limited Aurobindo Pharma Limited
Survey No. 313 and 314, Bachupally
Quthubullapur Mandal
Hyderabad, Andhra Pradesh
India - 500 072
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
73 NDA 22141 Lamivudine + Tenofovir Disoproxil Fumarate 300mg / 300mg Tablets Mylan 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
72  ANDA 090159 Abacavir Sulfate + Lamivudine 600mg / 300mg Tablets Aurobindo Pharma Limited Aurobindo Pharma Limited (Unit - III) Survey No. 313 & 314, Bachupally, Quthubullapur Mandal Hyderabad, Andhra Pradesh - 500 072 India 30's HDPE Bottles 10's Blisters Tentatively Approved 9/03/08
71 ANDA 077981 Zidovudine 50mg/5mL Oral solution Cipla Limited Cipla Limited L-139 to L-146 Verna Industrial Estate Goa- 403 722 India HDPE bottles with CRCs-100 mL and 240 mL  Approved 6/26/08
70 NDA 22167 Lamivudine + Stavudine 60mg / 12mg and 30mg / 6mg Tablets for Oral Suspension Cipla Limited Cipla 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 tablets Tentatively Approved 6/19/08
69 ANDA 078864 Nevirapine 200mg Tablets Mylan 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
68 ANDA 079188 Emtricitabine 200mg Capsules Aurobindo Pharma Limited Aurobindo 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
67 ANDA 090092 Zidovudine 300mg Tablets Hetero 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 Approved 4/25/08
66 ANDA 079124 Lamividine + Zidovudine 150mg / 300mg Tablets Hetero 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 Tentatively Approved 4/25/08
65 NDA 22177 Lamivudine / Stavudine / Nevirapine 150mg / 30mg / 200mg Tablets Strides Arcolab Limited Strides Arcolab Limited S-No, 36/7 Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore 562 106, INDIA
 
HDPE bottles containing 60 tablets Tentatively Approved 3/20/08
64 NDA 21837 Lamivudine / Stavudine / Nevirapine 150mg / 40mg / 200mg Tablets Strides Arcolab Limited Strides Arcolab Limited S-No, 36/7 Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore 562 106, INDIA
 
HDPE bottles containing 60 tablets Tentatively Approved 3/20/08
63 ANDA 078886 Efavirenz 600mg Tablets Hetero 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 Bottles Tentatively Approved 02/29/08
62 ANDA 078957 Stavudine 15mg / 20mg / 30mg / 40mg Capsules Hetero 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
61 ANDA 078922 Zidovudine 300mg Tablets Mylan 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
60 ANDA 078785 Atazanavir Sulfate 100mg / 150mg  / 200mg Capsules Emcure Pharmaceuticals Limited Emcure 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
59 ANDA 078850 Lamivudine 150mg / 300mg Tablets Hetero 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
58 ANDA 078958 Efavirenz 600mg Tablets Emcure Pharmaceuticals Limited Emcure 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 packs Tentatively Approved 12/20/2007
57 ANDA 078587 Stavudine 40mg Capsules Emcure Pharmaceuticals Limited Emcure 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
56 ANDA 079071 Tenofovir Disoproxil Fumarate 300mg Tablets Mylan 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
55 ANDA 079079 Lamivudine + Zidovudine 150mg / 300mg Tablets Mylan 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
54 NDA 22085 Lamivudine + Stavudine 150mg / 40mg and 150mg / 30mg Tablets Mylan 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
HDPE bottles of 60 Blister packs of 10
LDPE bags of 2500
Tentatively Approved 11/02/07
53 ANDA 078030 Stavudine 1mg/mL Oral Solution Cipla Limited

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

Approved 03/20/09
52 ANDA 078887 Nevirapine 200mg Tablets Emcure Pharmaceuticals Limited 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 09/28/07
51 NDA 21972 Lamivudine + Stavudine + Nevirapine  30mg / 6mg / 50mg
and
60mg / 12mg / 100mg
Dispersible Tablets  Cipla Limited Cipla 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
50 ANDA 078584 Nevirapine 200mg Tablets Hetero 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
49 ANDA 078929 Lamivudine + Zidovudine 150mg / 300mg Tablets Emcure Pharmaceuticals Limited Manufacturing 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
48 ANDA 078883  Efavirenz 600mg
 
Tablets Mylan 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
 
47 ANDA 078644 Nevirapine 200mg Tablets Huahai 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
46 NDA 22097 Stavudine / Lamivudine Co-packaged with Efavirenz 40mg / 150mg co-packaged with 600mg tablets Strides Arcolab Limited Strides 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
45 NDA 22096 Lamivudine / Zidovudine co-packaged with Efavirenz 150mg / 300mg co-packaged with Efavirenz Tablets, 600 mg Tablets Strides Arcolab Limited Strides 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
44  ANDA 078349 Zidovudine 100mg Capsules Cipla Limited Cipla Limited L138-147 L150 s103-105 Verna, Salcette, GOA 403 722 India HDPE Bottles 100´s and 1000´s Approved
05/23/07
43 ANDA 078775 Stavudine 30mg / 40mg Capsules Mylan 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
42 ANDA 078742 Abacavir Sulfate 300mg Tablets Mylan 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
41 ANDA 078509 Efavirenz 600mg Tablets Strides Arcolab Limited Strides Arcolab Limited 36/7, Suragajakkanahalli
Indlavadi Cross,
Anekal Taluk
Bangalore, India 562106
HDPE bottles of 30 Tentatively Approved
03/26/07
40 ANDA 078545 (number for 40 & 94) Lamivudine 300mg Tablets Mylan 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
39 NDA 21854 Stavudine / Lamivudine Co-packaged with Nevirapine 40mg / 150mg co-packaged with 200mg Tablets Strides Arcolab Limited Strides Arcolab Limited 36/7, Suragajakkanahalli
Indlavadi Cross
Anekal Taluk
Bangalore, India 560106
60 count of tablets-HDPE bottles with snap-on cap Tentatively Approved
03/13/07
38 NDA 21838 Stavudine + Lamivudine + Nevirapine 40mg / 150mg / 200mg Tablets Strides Arcolab Limited Strides Arcolab Limited 36/7, Suragajakkanahalli
Indlavadi Cross
Anekal Taluk
Bangalore, India 562106
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
37 NDA 21988 Lamivudine / Zidovudine Co-packaged with Nevirapine
 
150mg / 300mg co-packaged with 200mg Tablets Strides Arcolab Limited Strides Arcolab Limited 36/7 Suragajakkanahalli
Indlavadi Cross
Anekal Taluk
Bangalore, India 560106
HDPE bottles 60 + 60 Tentatively Approved
03/02/07
36 NDA 21971 Lamivudine + Zidovudine + Nevirapine 150mg / 300mg / 200mg Tablets Cipla Limited Cipla 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
35 NDA 21974 Lamivudine + Stavudine 150mg / 30mg or 40mg Tablets Cipla Limited Cipla 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
34 ANDA 078064 Efavirenz 50mg / 100mg / 200mg Capsules Aurobindo Pharma Limited Aurobindo Pharma Limited Unit III, Survey No. 313 &314 Bachupally, Quthubullapur Mandal Hyderabad, Andhra Pradesh India 500 072 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
33 NDA 21-969 Lamivudine + Stavudine + Nevirapine 150mg / 40mg / 200mg
and
150mg / 30mg / 200mg
 
Tablets Cipla Limited Cipla Limited
L-139 to 146 Verna Industrial Estate
Verna Goa 403 722
India
HDPE Bottle 30, 60, & 1000 Tentatively Approved
11/17/06
32 ANDA 078119 Abacavir Sulfate 300mg (base) Tablets Cipla Limited Cipla Limited, Manufacturing Division, Plot A-23/1/2 India, Patalganga Industrial Area
District – Raigad, Maharashtra, India
HDPE bottle 60's Tentatively Approved
11/06/06
31 ANDA 078112 Didanosine 10mg/mL Oral Solution Aurobindo Pharma, Limited Aurobindo Pharma Ltd, Unit III, Survey 313 & 314, Bachupally, Quthubullapur Mandal, Hyderabad, Andhra Pradesh, India 500 072 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
30 ANDA 077411 Lamivudine + Zidovudine 150mg / 300mg Tablets Cipla Limited Cipla Limited
L-139 to L-146
Verna Industrial Estate
Goa-403 722
Blisters 10's (PVC / PVDC film & Plain blister foil)

HDPE Bottles 60's

HDPE Bottles 1000's
Tentatively Approved
09/13/06
29 ANDA 078256 Stavudine 30mg and 40mg Capsules Strides Arcolab Limited Strides Arcolab Limited 36/7 Suragajakkanahalli Indlavadi cross, Anekal Taluk Bangalore - 560106, India HDPE Bottles of 60's Tentatively Approved
08/28/06
28 NDA 22-018 Lamivudine + Zidovudine 150mg / 300mg Tablets Pharmacare Limited Pharmacare 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
27 ANDA 078195 Nevirapine 200mg Tablets Strides Arcolabs Limited Strides Arcolabs Limited 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bangalore -560106, India HDPE bottle 60's Tentatively Approved
08/11/06

Approved 05/22/12
26 NDA 21-944 Lamivudine / Zidovudine Co-packaged with Abacavir 150mg / 300mg co-packaged with 300mg Tablets Aurbindo Pharma Limited Aurobindo 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 + 60 Tentatively Approved
07/26/06
25 ANDA 077275 Didanosine 100mg / 150mg / 200mg Tablets /  Chewable /  Dispersible /  Bufferred Aurbindo Pharma Limited Aurobindo Pharma Limited, Unit - III Survey No.: 13 Gaddapotharam IDA-Dazipally Jinnaram, Medak District Andhara Pradesh – 502 319 India HDPE bottles 60 Tentatively Approved
07/10/06

Approved 08/14/12
24 NDA 21939 Lamivudine + Zidovudine + Nevirapine 150mg / 300mg / 200mg Tablets Aurobindo Pharma Limited Aurobindo Pharma Limited, Unit III
Survey No. 313 & 314, Bachupally,
Quthubullapur Mandal Hyderabad,
Andhra Pradesh, India - 500 072
HDPE bottles 60

Blister cards 10
PVC / PVDC / Aluminum
Tentatively Approved
06/30/06
23 ANDA 077672 (number for 8 & 23) Stavudine 15mg / 20mg Capsules Aurobindo Pharma Limited Aurobindo Pharma Limited, Unit III
Survey No. 313 & 314, Bachupally,
Quthubullapur Mandal Hyderabad,
Andhra Pradesh, India - 500 072
HDPE Bottles 60's Tentatively Approved
06/27/06
22 ANDA 077950 Abacavir Sulfate 20mg/mL Oral Solution Aurobindo Pharma Limited Aurobindo Pharma Limited, Unit III
Survey No. 313 & 314, Bachupally,
Quthubullapur Mandal Hyderabad,
Andhra Pradesh, India - 500 072
HDPE Bottles 240 mL Tentatively Approved
06/27/06
21 ANDA 077980 Lamivudine 10mg/mL Oral Solution Cipla Limited Cipla Limited L-139 to L-146, Verna Industrial Estate, Goa -- 403 722 India HDPE bottles 100 mL and 240 mL Tentatively Approved
06/22/06
20 ANDA 077916  Efavirenz 600mg Tablets Cipla Limited Cipla Limited L-139 to L-146, Verna Industrial Estate, Goa -- 403 722 India HDPE Bottles 30 and 500 Tentatively Approved
05/24/06
19 ANDA 077956 Nevirapine 200mg Tablets Cipla Limited Cipla Limited L-139 to L-146, Verna Industrial Estate, Goa -- 403 722 India HDPE Bottles 60 and 1000 Tentatively Approved
05/19/06

Approved 05/22/12
18 ANDA 077844 Abacavir Sulfate 300mg Tablets Aurobindo Pharma Limited Aurobindo Pharma Limited Unit III, Survey No 313 Bachyupally, Quthubullapur Mandal Hyderabad, Andhra Pradesh India 500 072 HDPE bottles 60

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

Approved
12/17/12
17 ANDA 078128 Zidovudine 100 mg Capsule Aurobindo Pharma Limited Aurobindo Pharma Limited, Survey No 313 and 314, Bachupally Quthubullapur Mandal Hyderabad, Anda Pradesh India 500 072 HDPE Bottle 100



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


carton 60 + 30
Tentatively Approved
03/06/06
 
15 ANDA 077702 Nevirapine 50mg / 5mL Oral Suspension Aurobindo Pharma Limited Aurobindo Pharma Limited
Survey No. 313 and 314, Bachupally
Quthubullapur Mandal, Hyderabad
Andhra Pradesh, India - 500 072
HDPE Bottle 240 mL Tentatively Approved
12/29/05

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

Approved
12/29/08
13 ANDA 077695 Lamivudine 10mg/mL Oral Solution Aurobindo Pharma Limited Aurobindo Pharma Limited
 Unit III Survey No. 313, Bachupally, Quthubullapur Mandal, Hyderabad, Andhra Pradesh, India 500 072
HDPE Bottle 240 mL Tentatively Approved 11/08/05
12 ANDA 077268 Zidovudine 50 mg / mL Oral Solution Aurobindo Pharma Limited Aurobindo Pharma Limited
 Unit III Survey No. 313, Bachupally, Quthubullapur Mandal, Hyderabad, Andhra Pradesh, India 500 072
HDPE Bottles 240 mL Tentatively Approved 9/07/05

Approved 9/19/05
11 ANDA 077267 Zidovudine 300mg Tablets Aurobindo Pharma Limited Aurobindo Pharma Limited Survey No. 313, Bachupally, Quthubullapur, Hyderabad, Andhra Pradesh, India 500 072 HDPE Bottle 60 and Blister 10 Tentatively Approved 8/25/05; Approved 9/19/05
10 ANDA 077327 Zidovudine 300mg Tablets Ranbaxy Laboratories Limited Ranbaxy laboratories Limited, Paonta Sahib, District Sirmour,Himachal Pradesh 173 025 India Blister 8 and HDPE Bottle 60 Status is Withdrawn 9/21/20121

Tentatively Approved 7/13/05

Approved 9/19/05
9 ANDA 077558 Lamivudine + Zidovudine 150mg / 300mg Tablets Aurobindo Pharma Limited Aurobindo Pharma Limited Unit III Survey No. 313, Bachupally, Quthubullapur Mandal, Hyderabad, Andhra Pradesh, India 500 072 HDPE Bottle 60 and Blister 10 Tentatively Approved 7/07/05
8 ANDA 077672 (number for 8 & 23) Stavudine 15mg / 20mg / 30mg / 40mg Capsules Aurobindo Pharma Limited Aurobindo Pharma Limited Unit III Survey No. 313 and 314,Bachupally, Quthubullapur Mandal, Hyderabad, Andhra Pradesh, India 500 072 HDPE Bottle 60 Tentatively Approved 7/01/05

Approved 12/29/08
7 ANDA 077673 Efavirenz 600 mg Tablets Aurobindo Pharma Limited Aurobindo Pharma Limited Unit III Survey No. 313, Bachupally, Quthubullapur Mandal, Hyderabad, Andhra Pradesh, India 500 072 HDPE Bottle 30 and Blister 10 Tentatively Approved 6/24/05
6 ANDA 077521 Nevirapine 200mg Tablets Aurobindo Pharma Limited Aurobindo Pharma Limited Unit III Survey No. 313, Bachupally, Quthubullapur Mandal, Hyderabad, Andhra Pradesh, India 500 072 HDPE Bottle 60 and Blister 10 Tentatively Approved 6/20/05

Approved 05/22/12
5 ANDA 077464 Lamivudine 150mg and 300mg Tablets Aurobindo Pharma Limited Aurobindo Pharma Limited Unit III Survey No. 313, Bachupally, Quthubullapur Mandal, Hyderabad, Andhra Pradesh, India 500 072 HDPE Bottle 30 (300 mg) and HDPE Bottle 60 (150 mg) and Blister 10 Tentatively Approved 6/15/05
4 ANDA 077429 Nevirapine 200mg Tablets Ranbaxy Laboratories Limited Ranbaxy Laboratories Limited, Paonta Sahib, District Sirmour,Himachal Pradesh 173 025 India Blister 10 and HDPE Bottle 60, 1000 Tentatively Approves 5/27/05

Drug application subject to the consent decree of permanent injunction entered on 1/26/12; this drug is currently unavailable for PEPFAR purchase
3 ANDA 077357 Lamivudine   150mg Tablets Ranbaxy Laboratories Limited Ranbaxy Laboratories Limited, Paonta Sahib, District Sirmour,Himachal Pradesh 173 025 India HDPE Bottle 60 and Blister 10 Tentatively Approved 5/27/05

Drug application subject to the consent decree of permanent injunction entered on 1/26/12; this drug is currently unavailable for PEPFAR purchase
2 NDA 21841 Lamivudine / Zidovudine Co-packaged with Nevirapine 150mg / 300mg co-packaged with 200mg Tablets Pharmacare Limited 7 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
1 ANDA 077167 Didanosine 200mg, 250mg, 400mg Delayed Release Capsule Barr Barr Laboratories, Inc. 2 Quaker Rd. Pomona, NY 10970 HDPE Bottle 30 Approved 12/03/04

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