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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. (See FDA Guidance for Industry finalized October 2006: http://www.fda.gov/cder/guidance/6360fnl.pdf)

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

# Established Name
(INN)
Strength Dosage Form Supplier

Manufacturing Site Drug Product

Packaging Material and Pack

Date of FDA Approval or Tentative Approval

1 Didanosine 200 mg, 250 mg, 400 mg Delayed Release Capsule Barr Barr Laboratories, Inc. 2 Quaker Rd. Pomona, NY 10970 HDPE Bottle 30 Approved 12/03/04
2 Lamivudine+Zidovudine+Nevirapine 150/300 mg + 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
3 Lamivudine   150 mg 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
4 Nevirapine 200 mg 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
5 Lamivudine 150 mg and 300 mg 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
6 Nevirapine 200 mg 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

 
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
8 Stavudine 30 mg and 40 mg 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
9 Lamivudine+Zidovudine 150 mg/300 mg 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
10 Zidovudine 300 mg 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
11 Zidovudine 300 mg 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
12 Zidovudine 50 mg/5 ml 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
13 Lamivudine 10 mg/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
14 Stavudine
1 mg/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
15 Nevirapine 50 mg/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
16 Lamivudine+Zidovudine+ Efavirenz
150 mg/300
mg + 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
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
18 Abacavir Sulfate 300 mg 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
19 Nevirapine 200 mg 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
20 Efavirenz 600 mg 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
21 Lamivudine 10 mg/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
22 Abacavir Sulfate 20 mg/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
23 Stavudine 15mg/20 mg 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
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
25 Didanosine 100mg/150 mg/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
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
27 Nevirapine 200 mg 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
28 Lamivudine+Zidovudine 150 mg/300 mg 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
29 Stavudine 30 and 40 mg 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
30 Lamivudine+Zidovudine 150 mg/300 mg 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
31 Didanosine 10 mg/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
32 Abacavir Sulfate 300 mg (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
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
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
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
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
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
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
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
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
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
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
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
44 Zidovudine 100mg Capsules Cipla Limited Cipla Limited Ve3rna Industrial Estate GOA 403 722 India HDPE Bottles 100´s and 1000´s Approved
05/23/07
45 Lamivudine+Zidovudine+Efavirenz 150mg/300mg + 600mg Tablets Strides Arcolab 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
46 Stavudine+Lamivudine+Efavirenz 40mg/150mg + 600mg tablets Strides Arcolab 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
47 Nevirapine

 

 

 

 




200 mg Tablets Huahai US Inc. Zhejiang Huahai Pharmaceutical Co. Ltd.
Xunqiao, Linhai;
Zhejiang 317024;
China
Packaging:
HDPE bottles of 60
Tentatively Approved 07/10/07
48 Efavirenz 600 mg
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
49 Lamivudine+Zidovudine 150 mg/300 mg 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
50 Nevirapine 200 mg 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
51 Lamivudine+Stavudine+Nevirapine  30 mg/6 mg/50 mg
and
60 mg/12 mg/100 mg
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
52 Nevirapine 200 mg 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
53 Stavudine 1 mg/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
54 Lamivudine+Stavudine 150 mg/40 mg and 150 mg/30 mg 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
55 Lamivudine+Zidovudine 150 mg/300 mg 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
56 Tenofovir Disoproxil Fumarate 300 mg 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
57 Stavudine 40 mg 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
58 Efavirenz 600 mg 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
59 Lamivudine 150 mg/300 mg 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 01/29/2008
60 Atazanavir Sulfate 100 mg/150 mg/200 mg 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 02/04/2008
61 Zidovudine 300 mg 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 02/14/2008
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 02/28/2008
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 02/29/2008
64 Lamivudine+Stavudine+Nevirapine 150 mg/30 mg/200 mg & 150 mg/40 mg/200 mg 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
65 Lamividuine+Zidovudine 150 mg/300 mg 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
66 Zidovudine 300 mg 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
67 Emtricitabine 200 mg 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
68 Nevirapine 200 mg Tablets Matrix Laboratories Limited Matrix Laboratories Limited,
F-4 F-12 Malegaon MIDC, Sinnar
Nashik-422 113
Maharashtra, India
HDPE bottles of 100s
PVC Blister Packs of 10s
Tentatively Approved 5/15/08
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
70 Zidovudine 50 mg/5 mL 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
71 Abacavir Sulfate+Lamivudine 600 mg/300 mg 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
72 Lamivudine+Tenofovir Disoproxil Fumarate 300 mg/300 mg 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
73 Abacavir Sulfate 60 mg 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

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