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U.S. Department of Health and Human Services

Drugs

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Approvals - December 2003

 ANDA NumberGeneric Drug NameApplicantApproval Date
165-161AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP (CHEWABLE) 200 MG/28.5 MG (BASE) AND 400 MG/57 MG (BASE)  RANBAXY LABORATORIES LIMITED12/3/2003 
276-656FENOLDOPAM 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 
376-508BETAMETHASONE DIPROPIONATE GEL (AUGMENTED) 0.05% (BASE)  TARO PHARMACEUTICALS U.S.A., INC.12/2/2003 
465-159AMOXICILLIN TABLETS FOR ORAL SUSPENSION, USP 600 MG  RANBAXY LABORATORIES LIMITED12/4/2003 
576-461VINORELBINE TARTRATE INJECTION 10 MG (BASE)/ML, PACKAGED IN 10 MG (BASE)/1 ML AND 50 MG (BASE)/5 ML SINGLE-USE VIALS.  BEDFORD LABORATORIES12/11/2003 
676-592BETAMETHASONE DIPROPIONATE CREAM, USP (AUGMENTED) 0.05% (BASE)  CLAY-PARK LABS, INC.12/9/2003 
776-215BETAMETHASONE DIPROPIONATE CREAM, USP (AUGMENTED) 0.05% (BASE)  ALTANA, INC.12/9/2003 
876-543BETAMETHASONE DIPROPIONATE CREAM, USP (AUGMENTED) 0.05% (BASE)  TARO PHARMACEUTICALS USA, INC.12/9/2003 
976-282TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE) AND 4 MG (BASE)  ALPHAPHARM PTY. LTD.12/16/2003 
1076-666INDOMETHACIN CAPSULES, USP 25 MG AND 50 MG  ABLE LABORATORIES, INC.12/17/2003 
1176-307MIRTAZAPINE ORALLY DISINTEGRATING TABLETS 15 MG AND 30 MG  BARR LABORATORIES, INC.12/17/2003 
1276-732METOLAZONE TABLETS, USP 2.5 MG  EON LABS, INC.12/19/2003 
1376-466METOLAZONE TABLETS, USP 5 MG AND 10 MG  EON LABS, INC.12/19/2003 
1440-506ETHOSUXIMIDE SYRUP 250 MG/5 ML  MIKART, INC.12/22/2003 
1576-244MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG  IVAX PHARMACEUTICALS, INC.12/22/2003 
1665-092CEFACLOR TABLETS (CHEWABLE) 125 MG, 187 MG, 250 MG, AND 375 MG  RANBAXY LABORATORIES LIMITED12/22/2003 
1740-496BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLETS, USP 50 MG/750 MG/40 MG, RESPECTIVELY  MIKART, INC.12/23/2003 
1876-698METOLAZONE TABLETS, USP 2.5 MG  MYLAN PHARMACEUTICALS, INC.12/23/2003 
1975-543METOLAZONE TABLETS, USP 10 MG  TEVA PHARMACEUTICALS USA12/24/2003 
2075-808NORGESTIMATE 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 
2176-392MEFLOQUINE HYDROCHLORIDE TABLETS 250 MG  BARR LABORATORIES, INC.12/29/2003 
2276-604HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS 7.5 MG/200 MG  ANDRX PHARMACEUTICALS, LLC