International Programs
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President's Emergency Plan for AIDS Relief
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:
- 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.
- 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.
- 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.
- 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 Number | Established Name | Strength | Dosage Form | Supplier | Manufacturing Site Drug Product | Packaging Material and Pack | Date of FDA Approval or Tentative Approval |
|---|---|---|---|---|---|---|---|---|
| 153 | 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 |
| 152 | ANDA 201107 | Abacavir | 20 mg / mL | Oral Solution | Hetero Drugs 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 opaque bottles, 240 mL | Tentative Approved 07/02/2012 |
| 151 | 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 |
| 150 | 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 |
| 149 | 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 |
| 148 | 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 |
| 147 | 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 |
| 146 | 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 |
| 145 | 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 |
| 144 | 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 |
| 143 | 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 |
| 142 | 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 |
| 141 | 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 |
| 140 | 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 |
| 139 | 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 |
| 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 |
| 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 | 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 |
| 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 |
| 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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