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U.S. Department of Health and Human Services

Drugs

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Approvals - December 2003

  ANDA Number Generic Drug Name Applicant Approval Date
1 65-161 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP (CHEWABLE) 200 MG/28.5 MG (BASE) AND 400 MG/57 MG (BASE)   RANBAXY LABORATORIES LIMITED 12/3/2003 
2 76-656 FENOLDOPAM MESYLATE INJECTION, USP 10 MG (BASE)/ML; PACKAGED IN 10 MG (BASE)/1 ML AND 20 MG (BASE)/2 ML SINGLE-DOSE AMPULES   PHARMAFORCE, INC. 12/1/2003 
3 76-508 BETAMETHASONE DIPROPIONATE GEL (AUGMENTED) 0.05% (BASE)   TARO PHARMACEUTICALS U.S.A., INC. 12/2/2003 
4 65-159 AMOXICILLIN TABLETS FOR ORAL SUSPENSION, USP 600 MG   RANBAXY LABORATORIES LIMITED 12/4/2003 
5 76-461 VINORELBINE TARTRATE INJECTION 10 MG (BASE)/ML, PACKAGED IN 10 MG (BASE)/1 ML AND 50 MG (BASE)/5 ML SINGLE-USE VIALS.   BEDFORD LABORATORIES 12/11/2003 
6 76-592 BETAMETHASONE DIPROPIONATE CREAM, USP (AUGMENTED) 0.05% (BASE)   CLAY-PARK LABS, INC. 12/9/2003 
7 76-215 BETAMETHASONE DIPROPIONATE CREAM, USP (AUGMENTED) 0.05% (BASE)   ALTANA, INC. 12/9/2003 
8 76-543 BETAMETHASONE DIPROPIONATE CREAM, USP (AUGMENTED) 0.05% (BASE)   TARO PHARMACEUTICALS USA, INC. 12/9/2003 
9 76-282 TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE) AND 4 MG (BASE)   ALPHAPHARM PTY. LTD. 12/16/2003 
10 76-666 INDOMETHACIN CAPSULES, USP 25 MG AND 50 MG   ABLE LABORATORIES, INC. 12/17/2003 
11 76-307 MIRTAZAPINE ORALLY DISINTEGRATING TABLETS 15 MG AND 30 MG   BARR LABORATORIES, INC. 12/17/2003 
12 76-732 METOLAZONE TABLETS, USP 2.5 MG   EON LABS, INC. 12/19/2003 
13 76-466 METOLAZONE TABLETS, USP 5 MG AND 10 MG   EON LABS, INC. 12/19/2003 
14 40-506 ETHOSUXIMIDE SYRUP 250 MG/5 ML   MIKART, INC. 12/22/2003 
15 76-244 MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG   IVAX PHARMACEUTICALS, INC. 12/22/2003 
16 65-092 CEFACLOR TABLETS (CHEWABLE) 125 MG, 187 MG, 250 MG, AND 375 MG   RANBAXY LABORATORIES LIMITED 12/22/2003 
17 40-496 BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLETS, USP 50 MG/750 MG/40 MG, RESPECTIVELY   MIKART, INC. 12/23/2003 
18 76-698 METOLAZONE TABLETS, USP 2.5 MG   MYLAN PHARMACEUTICALS, INC. 12/23/2003 
19 75-543 METOLAZONE TABLETS, USP 10 MG   TEVA PHARMACEUTICALS USA 12/24/2003 
20 75-808 NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS 0.180 MG/0.035 MG, 0.215 MG/0.035 MG, 0.250 MG/0.035 MG, PACKAGED AS A TRIPHASIC REGIMEN (28-DAY CYCLE)   BARR LABORATORIES, INC. 12/29/2003 
21 76-392 MEFLOQUINE HYDROCHLORIDE TABLETS 250 MG   BARR LABORATORIES, INC. 12/29/2003 
22 76-604 HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS 7.5 MG/200 MG   ANDRX PHARMACEUTICALS, LLC

 

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