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Approvals - September 2005

  ANDA Number Generic Drug Name Applicant Approval Date
1 76-447 FEXOFENADINE HYDROCHLORIDE TABLETS, 30 MG, 60 MG, AND 180 MG   TEVA PHARMACEUTICALS, USA 9/1/2005 
2 77-113 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 750 MG   MYLAN PHARMACEUTICALS, INC. 9/8/2005 
3 77-353 ALLOPURINOL TABLETS USP, 100 MG AND 300 MG   APOTEX INC. 9/8/2005 
4 77-483 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS, 5 MG/6.25 MG, 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG   RANBAXY LABORATORIES LIMITED 9/8/2005 
5 77-115 MIDAZOLAM HYDROCHLORIDE SYRUP, 2 MG (BASE)/ML   APOTEX INC. 9/9/2005 
6 77-321 LISINOPRIL TABLETS USP, 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG   LUPIN LIMITED 9/9/2005 
7 76-650 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 500 MG   MYLAN PHARMACEUTICALS, INC. 9/13/2005 
8 76-985 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 750 MG   IMPAX LABORATORIES, INC. 9/13/2005 
9 77-083 LEFLUNOMIDE TABLETS, 10 MG AND 20 MG   BARR LABORATORIES, INC. 9/13/2005 
10 77-084 LEFLUNOMIDE TABLETS, 10 MG AND 20 MG   TEVA PHARMACEUTICALS USA 9/13/2005 
11 77-085 LEFLUNOMIDE TABLETS, 10 MG AND 20 MG   SANDOZ, INC. 9/13/2005 
12 77-086 LEFLUNOMIDE TABLETS, 10 MG AND 20 MG   KALI LABORATORIES, INC. 9/13/2005 
13 77-087 LEFLUNOMIDE TABLETS, 10 MG AND 20 MG   SANDOZ, INC. 9/13/2005 
14 77-090 LEFLUNOMIDE TABLETS, 10 MG AND 20 MG   APOTEX, INC. 9/13/2005 
15 76-605 GABAPENTIN TABLETS, 60O MG AND 800 MG   RANBAXY LABORATORIES LIMITED 9/14/2005 
16 76-498 TRETINOIN CREAM USP (EMOLLIENT), 0.05%   SPEAR PHARMACEUTICALS 9/15/2005 
17 76-587 ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05%   TARO PHARMACEUTICALS USA, INC. 9/15/2005 
18 77-314 NIZATIDINE CAPSULES USP, 150 MG AND 300 MG   DR. REDDY'S LABORATORIES LIMITED 9/15/2005 
19 40-590 ERGOTAMINE TARTRATE AND CAFFEINE TABLETS USP, 1 MG/100 MG   MIKART, INC. 9/16/2005 
20 76-844 ZIDOVUDINE TABLETS USP, 300 MG   ROXANE LABORATORIES, INC. 9/19/2005 
21 77-267 ZIDOVUDINE TABLETS USP, 300 MG   AUROBINDO PHARMA LIMITED 9/19/2005 
22 77-268 ZIDOVUDINE ORAL SOLUTION USP, 50 MG/5 ML   AUROBINDO PHARMA LIMITED 9/19/2005 
23 77-327 ZIDOVUDINE TABLETS USP, 300 MG   RANBAXY LABORATORIES LIMITED 9/19/2005 
24 77-139 CARBOPLATIN INJECTION, 10 MG/ML; 5 ML, 15 ML, 45 ML, AND 60 ML VIALS   SICOR PHARMACEUTICALS, INC. 9/21/2005 
25 65-170 MUPIROCIN OINTMENT USP, 2 %   TARO PHARMACEUTICALS U.S.A., INC. 9/23/2005 
26 75-677 ACYCLOVIR CAPSULES USP, 200 MG   APOTEX INC. 9/28/2005 
27 76-957 FLUCONAZOLE TABLETS, 50 MG, 100 MG, AND 200 MG   UNIQUE PHARMACEUTICAL LABORATORIES 9/28/2005 
28 76-961 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS, 10 MG/12.5 MG AND 20 MG/12.5 MG   SANDOZ INC. 9/28/2005 
29 77-246 DANAZOL CAPSULES USP, 200 MG   LANNETT HOLDINGS, INC. 9/28/2005 
30 77-442 PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP, 120 MG   RANBAXY LABORATORIES LIMITED 9/28/2005 
31 40-626 PRIMIDONE TABLETS USP, 50 MG AND 250 MG   MUTUAL PHARMACEUTICAL COMPANY, INC. 9/29/2005 
32 77-309 ACYCLOVIR TABLETS USP, 400 MG AND 800 MG   APOTEX INC. 9/29/2005 

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Date created: October 12, 2005

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