Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail
-

Approvals - September 2004

  ANDA Number Generic Drug Name Applicant Approval Date
1 75-987 OXAPROZIN TABLETS, USP 600 MG   TORPHARM, INC. 9/2/2004 
2 76-352 AMANTADINE HYDROCHLORIDE SYRUP, USP 50 MG/ 5 ML   SILARX PHARMACEUTICALS, INC. 9/10/2004 
3 76-372 BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.2%   IVAX PHARMACEUTICALS, INC. 9/10/2004 
4 76-639 CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG   UNIQUE PHARMACEUTICAL LABORATORIES 9/10/2004 
5 76-865 FLUTICASONE PROPIONATE CREAM 0.05%   KV PHARMACEUTICAL COMPANY 9/10/2004 
6 76-775 NICOTINE POLACRILEX GUM, USP (OTC) 2 MG (BASE) REGULAR FLAVOR   L. PERRIGO COMPANY 9/16/2004 
7 76-776 NICOTINE POLACRILEX GUM, USP (OTC) 2 MG (BASE) ORANGE FLAVOR   L. PERRIGO COMPANY 9/16/2004 
8 76-777 NICOTINE POLACRILEX GUM, USP (OTC) 2 MG (BASE) MINT FLAVOR   L. PERRIGO COMPANY 9/16/2004 
9 76-778 NICOTINE POLACRILEX GUM, USP (OTC) 4 MG (BASE) ORANGE FLAVOR   L. PERRIGO COMPANY 9/16/2004 
10 76-779 NICOTINE POLACRILEX GUM, USP (OTC) 4 MG (BASE) MINT FLAVOR   L. PERRIGO COMPANY 9/16/2004 
11 76-789 NICOTINE POLACRILEX GUM, USP (OTC) 4 MG (BASE) REGULAR FLAVOR   L. PERRIGO COMPANY 9/16/2004 
12 40-510 ERGOTAMINE TARTRATE AND CAFFEINE TABLETS, USP 1 MG/100 MG   WEST-WARD PHARMACEUTICAL CORP. 9/17/2004 
13 65-133 CYCLOSPORIN ORAL SOLUTION, USP 100 MG/ML   MORTON GROVE PHARMACEUTICALS, INC. 9/17/2004 
14 76-751 MESALAMINE RECTAL SUSPENSION, USP (ENEMA) 4 G/60 ML   AGIS INDUSTRIES (1983), LTD. 9/17/2004 
15 76-729 CARBAMAZEPINE ORAL SUSPENSION, USP 100 MG/5 ML   TARO PHARMACEUTICAL INDUSTRIES, LTD. 9/20/2004 
16 76-858 LEVOCARNITINE TABLETS, USP 330 MG   COREPHARMA LLC 9/20/2004 
17 76-427 MILRINONE LACTATE INJECTION 1 MG (BASE)/ML; PACKAGED IN 10 MG (BASE)/10 ML AND 20 MG (BASE)/20 ML SINGLE-DOSE VIALS   APOTEX CORP. 9/21/2004 
18 76-557 LORATADINE AND PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABL 10 MG/240 MG (OTC) (24-HOUR FORMULATION)   RANBAXY LABORATORIES LIMITED 9/22/2004 
19 76-925 IBUPROFEN ORAL SUSPENSION, USP 100 MG/5 ML   PERRIGO R & D COMPANY 9/23/2004 
20 65-174 CLARITHROMYCIN TABLETS, USP 250 MG AND 500 MG   RANBAXY LABORATORIES LIMITED 9/24/2004 
21 65-206 CLINDAMYCIN INJECTION, USP 150 MG/ML (PHARMACY BULK PACKAGE)   BEDFORD LABORATORIES 9/24/2004 
22 76-962 BROMOCRIPTINE MESYLATE TABLETS, USP 2.5 MG (BASE)   MYLAN PHARMACEUTICALS, INC. 9/24/2004 
23 40-415 WARFARIN SODIUM TABLETS, USP 1 MG, 2 MG, 2.5 MG, 3 MG, 4 MG, 5 MG, 6 MG, 7.5 MG, AND 10 MG   GENPHARM INC. 9/27/2004 
24 76-318 OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS 80 MG   IMPAX LABORATORIES, INC. 9/27/2004 
25 76-068 DEXRAZOXANE FOR INJECTION 250 MG AND 500 MG; PACKAGED IN SINGLE-DOSE VIALS   BEDFORD LABORATORIES 9/28/2004 
26 76-464 HALOPERIDOL INJECTION, USP 5 MG/ML; PACKAGED IN 1 ML AMPULES   SABEX 2002 INC. 9/29/2004 
27 76-783 NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS, USP 0.5 MG/0.035 MG AND 1 MG/0.035 MG (28-DAY REGIMEN) (ARANELLE TABLETS)   BARR LABORATORIES, INC. 9/29/2004 
28 76-911 CLORAZEPATE DIPOTASSIUM TABLETS, USP 3.75 MG, 7.5 MG, AND 15 MG   RANBAXY LABORATORIES LIMITED 9/29/2004 
29 40-522 NOREPINEPHRINE BITARTRATE INJECTION, USP 1 MG (BASE)/ML; PACKAGED IN 4 MG (BASE)/4 ML AMPOULES   PHARMAFORCE, INC. 9/30/2004 
30 76-321 TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE) AND 4 MG (BASE)   IVAX PHARMACEUTICALS, INC. 9/30/2004 
31 76-841 MESALAMINE RECTAL SUSPENSION, USP (ENEMA) 4 G/60 ML   TEVA PHARMACEUTICALS USA 9/30/2004 

 

-
-