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U.S. Department of Health and Human Services

Drugs

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Approvals - September 2003

  ANDA Number Generic Drug Name Applicant Approval Date
1 76-220 OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG   RANBAXY LABORATORIES LIMITED 9/2/2003 
2 76-093 OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG   PAR PHARMACEUTICAL, INC. 9/2/2003 
3 76-182 OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG   TEVA PHARMACEUTICALS USA 9/2/2003 
4 75-958 MIDAZOLAM HYDROCHLORIDE SYRUP 2 MG (BASE)/ML   HI-TECH PHARMACAL CO., INC. 9/4/2003 
5 76-094 PERGOLIDE MESYLATE TABLETS, USP 0.05 MG (BASE), 0.25 MG (BASE), AND 1 MG (BASE)   IVAX PHARMACEUTICALS S.R.O. 9/4/2003 
6 76-163 AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML; PACKAGED IN 150 MG/3 ML, 450 MG/9 ML, AND 900 MG/18 ML SINGLE-USE VIALS   SICOR PHARMACEUTICALS, INC. 9/5/2003 
7 40-535 OXYCODONE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/325 MG AND 10 MG/325 MG   WATSON LABORATORIES, INC. 9/5/2003 
8 76-514 MIDODRINE HYDROCHLORIDE TABLETS 2.5 MG AND 5 MG   EON LABS, INC. 9/11/2003 
9 76-467 GLIPIZIDE EXTENDED-RELEASE TABLETS 5 MG   WATSON LABORATORIES, INC. 9/8/2003 
10 40-480 AMPHETAMINE AND DEXTROAMPHETAMINE TABLETS (MIXED SALTS) 5 MG, 7.5 MG, 10 MG, 12.5 MG, 15 MG, 20 MG, AND 30 MG   MUTUAL PHARMACEUTICAL COMPANY, INC. 9/9/2003 
11 40-313 PREDNISOLONE SYRUP, USP 15 MG/5 ML   MORTON GROVE PHARMACEUTICALS, INC. 9/10/2003 
12 76-429 PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 MG/500 MG   AAI PHARMA 9/10/2003 
13 76-577 MIDODRINE HYDROCHLORIDE TABLETS 2.5 MG, 5 MG, AND 10 MG   MYLAN PHARMACEUTICALS, INC. 9/10/2003 
14 76-254 BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.2%   ALCON INC. 9/16/2003 
15 76-302 NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG   EON LABS, INC. 9/16/2003 
16 65-100 CEPHALEXIN TABLETS FOR ORAL SUSPENSION 125 MG AND 250 MG   RANBAXY LABORATORIES LIMITED 9/11/2003 
17 75-350 GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG   PUREPAC PHARMACEUTICAL CO. 9/12/2003 
18 75-145 SELEGILINE HYDROCHLORIDE CAPSULES 5 MG   AAI PHARMA 9/15/2003 
19 75-763 NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG   IVAX PHARMACEUTICALS, INC. 9/16/2003 
20 76-072 NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG   GENEVA PHARMACEUTICALS, INC. 9/16/2003 
21 76-409 NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG   RANBAXY LABORATORIES LIMITED 9/16/2003 
22 76-037 NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG   TEVA PHARMACEUTICALS USA 9/16/2003 
23 76-309 NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG   DR. REDDY'S LABORATORIES LIMITED 9/16/2003 
24 76-196 NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG   ROXANE LABORATORIES, INC. 9/16/2003 
25 76-129 NEFAZODONE HYDROCHLORIDE TABLETS 100 MG, 150 MG, 200 MG, AND 250 MG   MYLAN PHARMACEUTICALS, INC. 9/16/2003 
26 76-073 NEFAZODONE HYDROCHLORIDE TABLETS 100 MG, 150 MG, 200 MG, AND 250 MG   WATSON LABORATORIES, INC. 9/16/2003 
27 76-206 CALCITRIOL INJECTION 0.001 MG/ML (1 MCG/ML)   LYNE LABORATORIES, INC. 9/17/2003 
28 76-064 NORETHINDRONE ACETATE & ETHINYL ESTRADIOL TABLETS, USP & F 1.5 MG/30 MCG (WITH FERROUS FUMARATE, 75 MG)   BARR LABORATORIES, INC. 9/18/2003 
29 76-081 NORETHINDRONE ACETATE & ETHINYL ESTRADIOL TABLETS, USP & FER 1 MG/20 MCG (AND FERROUS FUMARATE, 75 MG)   BARR LABORATORIES, INC. 9/18/2003 
30 40-451 CYANOCOBALAMIN INJECTION, USP 1,000 MCG/ML (1 MG/ML) PACKAGED IN 10 ML MULTIPLE-DOSE VIALS.   PHARMAFORCE, INC. 9/23/2003 
31 65-124 CEFOTAXIME FOR INJECTION, USP 500 MG, 1 G, AND 2 G/VIAL   LUPIN LIMITED 9/24/2003 
32 40-482 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ORAL SOLUTION 7.5 MG/325 MG PER 15 ML   MIKART INC. 9/25/2003 
33 76-290 LIDOCAINE AND PRILOCAINE CREAM 2.5%/2.5%   HI-TECH PHARMACAL CO., INC. 9/25/2003 
34 75-746 CALCITRIOL INJECTION 0.001 MG/ML (1 MCG/ML) AND 0.002 MG/ML (2 MCG/ML) PACKAGED IN 1 ML SINGLE-USE AMPULES   LUITPOLD PHARMACEUTICALS, INC. 9/26/2003 
35 76-525 CARBAMAZEPINE TABLETS, USP 200 MG   TARO PHARMACEUTICAL INDUSTRIES, LTD. 9/26/2003 
36 76-011 LORATADINE ORALLY DISINTEGRATING TABLETS (OTC) 10 MG   IMPAX LABORATORIES, INC. 9/29/2003 
37 65-125 CEFTRIAXONE FOR INJECTION, USP 250 MG, 500 MG, 1 G, AND 2 G/SINGLE-USE VIAL   LUPIN LIMITED 9/30/2003 
38 40-472 AMPHETAMINE AND DEXTROAMPHETAMINE TABLETS (MIXED SALTS) 5 MG, 10 MG, 20 MG, AND 30 MG   ABRIKA PHARMACEUTICALS, LLLP 9/30/2003 
39 40-537 CYPROHEPTADINE HYDROCHLORIDE TABLETS, USP 4 MG   COREPHARMA LLC 9/30/2003 
40 76-416 TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE) AND 4 MG (BASE)   CARACO PHARMACEUTICAL LABORATORIES, LTD. 9/29/2003 
41 40-518 BETHANECHOL CHLORIDE TABLETS, USP 50 MG   WOCKHARDT LIMITED 9/29/2003 
42 40-532 BETHANECHOL CHLORIDE TALBETS, USP 5 MG   WOCKHARDT LIMITED 9/29/2003 
43 40-534 BETHANECHOL CHLORIDE TABLETS, USP 25 MG   WOCKHARDT LIMITED 9/29/2003 
44 40-533 BETHANECHOL CHLORIDE TABLETS 10 MG   WOCKHARDT LIMITED 9/29/2003 

 

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