-
International Programs
-
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
« Return to Presidential Emergency Plan for AIDS Relief (PEPFAR)
| # | Established Name | Strength | Dosage Form | Supplier | Manufacturing Site Drug Product | Packaging Material and Pack | Date of FDA Approval or Tentative Approval |
|---|---|---|---|---|---|---|---|
| 100 | Efavirenz / Emtricitabine / Tenofovir Disoproxil Fumarate | 600 mg / 200 mg / 300 mg | Tablets | Matrix Laboratories Limited | Matrix 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 |
| 99 | 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 |
| 98 | 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 |
| 97 | 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 |
| 96 | 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 |
| 95 | 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 |
| 94 | Abacavir Sulfate / Lamivudine / Zidovudine | 300 mg / 150 mg / 300 mg | Tablets | Matrix Laboratories Limited | Matrix Laboratories Ltd. Malegaon M.I.D.C. Shinnar, Nashik-422113 Maharashtra State, India | HDPE Bottles 60's | Tentative Approval 07/15/09 |
| 93 | Lamividune | 300mg | Tablets | Matrix Laboratories Limited | Matrix 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 |
| 92 | 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 |
| 91 | Lamivudine / Zidovudine Tablets Co-packaged with Nevirapine Tablets | 150 mg / 300mg co-packaged with 200mg | Co-packaged Tablets | Hetero Drugs Limited | Hetero Drugs Limited, Hyderabad, Andhra Pradesh, 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 |
| 90 | 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 |
| 89 | 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 |
| 88 | 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 |
| 87 | Abacavir Sulfate and Lamivudine | 600mg / 300mg | Tablets | Matrix Laboratories Limited | Matrix Laboratories Ltd., F-4 & F-12, Malegaon MIDC, Sinnar Nashik-422 113, Maharashtra, India | HDPE Bottles with 30’s | Tentative Approval 03/30/09 |
| 86 | Emtricitabine and Tenofovir Disoproxil Fumarate | 200mg / 300mg | Tablets | Matrix Laboratories Limited | Matrix 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 |
| 85 | Stavudine and Lamivudine | 30mg / 150mg and 40mg / 150mg | Fixed-Dose Combination Tablets | Pharmacare Limited | Strides Arcolab Limited S-No, 36/7Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore 562 106, INDIA | HDPE fitted with tear-off LDPE caps 60's | Tentative Approval 03/18/09 |
| 84 | 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 |
| 83 | 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 |
| 82 | Lopinavir / Ritonavir | 200mg / 50mg | Tablets | Matrix Laborabories Limited | Matrix Laboratories Ltd. 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 |
| 81 | Stavudine Lamivudine + Nevirapine | 30mg / 150mg / 200mg and 40mg / 150mg / 200mg | Fixed-Dose Combination Tablets | Pharmacare Limited | Strides Arcolab Limited S-No, 36/7Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore 562 106, INDIA | HDPE bottles containing 60 tablets | Tentative Approval 2/27/09 |
| 80 | 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 |
| 79 | Emtricitabine | 200mg | Capsules | Matrix Laboratories Limited | Matrix 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 |
| 78 | 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 |
| 77 | 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 |
| 76 | Lamivudine + Nevirapine + Zidovudine | 150mg / 200mg / 300mg | Tablets | Matrix Laboratories Limited | Matrix Laboratories Ltd, 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 |
| 75 | 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 |
| 74 | 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 |
| 73 | 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 |
| 72 | Lamivudine + Tenofovir Disoproxil Fumarate | 300mg / 300mg | Tablets | Matrix Laboratories Limited, Secunderabad, Andhra Pradesh, India | Matrix 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 |
| 71 | 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 |
| 70 | 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 |
| 69 | 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 |
| 68 | Nevirapine | 200mg | Tablets | Matrix Laboratories Limited | Matrix 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 |
| 67 | 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 |
| 66 | Zidovudine | 300mg | Tablets | Hetero Drugs Limited | Hetero Drugs 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 |
| 65 | Lamividine + Zidovudine | 150mg / 300mg | Tablets | Hetero Drugs Limited | Hetero Drugs 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 |
| 64 | Lamivudine + Stavudine + Nevirapine | 150mg / 30mg / 200mg & 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 | Efavirenz | 600mg | Tablets | Hetero Drugs Limited | Hetero Drugs 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 | Stavudine | 15mg / 20mg / 30mg / 40mg | Capsules | Hetero Drugs Limited | Hetero Drugs 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 | Zidovudine | 300mg | Tablets | Matrix Laboratories Limited |
Matrix Laboratories Ltd., 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 | 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 | Lamivudine | 150mg / 300mg | Tablets | Hetero Drugs Limited | Hetero Drugs 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 | 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 | 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 | Tenofovir Disoproxil Fumarate | 300mg | Tablets | Matrix Laboratories Limited | Matrix 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 | Lamivudine + Zidovudine | 150mg / 300mg | Tablets | Matrix Laboratories Limited |
Matrix 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 | Lamivudine + Stavudine | 150mg / 40mg and 150mg / 30mg | Tablets | Matrix Laboratories Limited | Matrix 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 | 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 | 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 | 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 | Nevirapine | 200mg | Tablets | Hetero Drugs, Limited | Hetero Drugs 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 |
| 49 | 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 | Efavirenz | 600mg |
Tablets | Matrix Laboratories Limited | Matrix Laboratories Ltd., 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 | 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 |
| 46 | Stavudine + Lamivudine + Efavirenz | 40mg / 150mg + 600mg | tablets | Strides Arcolab | 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 | Lamivudine + Zidovudine + Efavirenz | 150mg / 300mg + 600mg | Tablets | Strides Arcolab | 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 | 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 | Stavudine | 30mg / 40mg | Capsules | Matrix Laboratories Limited | Matrix 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 | Abacavir Sulfate | 300mg | Tablets | Matrix Laboratories, Limited | Matrix 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 | 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 | Lamivudine | 150mg | Tablets | Matrix Laboratories Limited | Matrix 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 | Stavudine + Lamivudine | 40mg / 150mg | Tablets | Strides Arcolab Limited | Strides Arcolab Limited 36/7, Suragajakkanahalli Indlavadi Cross Anekal Taluk Bangalore, India 560106 |
60 count of Lamivudine/Stavudine tablets-HDPE bottles with snap-on cap | Tentatively Approved 03/13/07 |
| 38 | 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 | Lamivudine + Zidovudine + Nevirapine |
150mg / 300mg / 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| 26 | Lamivudine + Zidovudine + Abacavir Sulfate | 150mg / 300mg + 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 | Didanosine | 100mg / 150mg / 200mg | Tablets/ Chewable/ Dispersible/ Bufferred | Aurbindo Pharma Limited | Aurobindo Pharma Limited, Unit - VIII Survey No.: 13 Gaddapotharam IDA-Dazipally Jinnaram, Medak District Andhara Pradesh – 502 319 India | HDPE bottles 60 | Tentatively Approved 07/10/06 |
| 24 | 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 | 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 | 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 | 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 | 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 | 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 |
| 18 | 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 | 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 | Lamivudine + Zidovudine + Efavirenz |
150mg / 300mg + 600mg | Tablets | Aurobindo | Aurobindo Pharma Ltd (Unit III) 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 | Nevirapine | 50mg / 5mL | Oral Suspension | Aurobindo | Aurobindo Pharma Ltd Survey No. 313 and 314, Bachupally Quthubullapur Mandal, Hyderabad Andhra Pradesh, India - 500 072 |
HDPE Bottle 240 mL | Tentatively Approved 12/29/05 |
| 14 | Stavudine |
1mg/mL | Oral Solution | Aurobindo |
Aurobindo Pharma Ltd 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 | Lamivudine | 10mg/mL | Oral Solution | Aurobindo | Aurobindo Pharma Ltd Unit III Survey No. 313, Bachupally, Quthubullapur Mandal, Hyderabad, Andhra Pradesh, India 500 072 | HDPE Bottle 240 mL | Tentatively Approved 11/08/05 |
| 12 | Zidovudine | 50mg / 5ml | Oral Solution | Aurobindo | Aurobindo Pharma Ltd Unit III Survey No. 313, Bachupally, Quthubullapur Mandal, Hyderabad, Andhra Pradesh, India 500 072 | HDPE Container | Tentatively Approved 9/07/05 Approved 9/19/05 |
| 11 | Zidovudine | 300mg | Tablets | Aurobindo | Aurobindo Pharma Ltd 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 | Zidovudine | 300mg | Tablets | Ranbaxy | 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 | Lamivudine + Zidovudine | 150mg / 300mg | Tablets | Aurobindo | Aurobindo Pharma Ltd 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 | Stavudine | 15mg / 20mg / 30mg / 40mg | Capsules | Aurobindo | Aurobindo Pharma Ltd 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 | Efavirenz | 600 mg | Tablets | Aurobindo | Aurobindo Pharma Ltd 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 | Nevirapine | 200mg | Tablets | Aurobindo | Aurobindo Pharma Ltd 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
|
| 5 | Lamivudine | 150mg and 300mg | Tablets | Aurobindo | Aurobindo Pharma Ltd 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 | Nevirapine | 200mg | Tablets | Ranbaxy | 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 | Lamivudine | 150mg | Tablets | Ranbaxy | Ranbaxy Laboratories Limited, Paonta Sahib, District Sirmour,Himachal Pradesh 173 025 India | HDPE Bottle 60 and Blister 10 | Tentatively Approved 5/27/05 |
| 2 | Lamivudine + Zidovudine + Nevirapine | 150mg / 300mg + 200 mg | Tablets |
Aspen Pharmacare Ltd
|
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 1/25/05 |
| 1 | Didanosine | 200mg, 250mg, 400mg | Delayed Release Capsule | Barr | Barr Laboratories, Inc. 2 Quaker Rd. Pomona, NY 10970 | HDPE Bottle 30 | Approved 12/03/04 |
-
-