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U.S. Department of Health and Human Services

Drugs

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Approvals - July 2004

 ANDA NumberGeneric Drug NameApplicantApproval Date
140-558PROMETHAZINE HYDROCHLORIDE TABLETS, USP 12.5 MG, 25 MG, AND 50 MG  ABLE LABORATORIES, INC.7/1/2004 
276-652GLYCOLAX (POLYETHYLENE GLYCOL 3350 POWDER FOR ORAL SOLUTION)  SCHWARZ PHARMA, INC.7/2/2004 
365-157PIPERACILLIN FOR INJECTION, USP 40 G/VIAL (PHARMACY BULK PACKAGE)  ISTITUTO BIOCHIMICO ITALIANO, S.P.A.7/12/2004 
465-203NYSTATIN TOPICAL POWDER, USP 100,000 UNITS/GRAM  TANON PHARMACEUTICALS LLC7/15/2004 
576-020MIDAZOLAM HYDROCHLORIDE INJECTION 1 MG (BASE)/ML AND 5 MG (BASE)/ML  INTERNATIONAL MEDICATION SYSTEMS, LIMITE7/16/2004 
676-853TERBUTALINE SULFATE INJECTION, USP 1 MG/ML; PACKAGED IN 1 ML SINGLE-DOSE VIALS  SICOR PHARMACEUTICALS, INC.7/20/2004 
775-772KETOROLAC TROMETHAMINE INJECTION, USP 15 MG/ML, 30 MG/ML, AND 60 MG/2 ML; SINGLE-DOSE VIALS.  BAXTER HEALTHCARE CORPORATION7/21/2004 
876-209KETOROLAC TROMETHAMINE INJECTION, USP 15 MG/ML, 30 MG/ML, AND 60 MG/2 ML, PACKAGED IN SINGLE-DOSE VIALS  AMPHASTAR PHARMACEUTICALS, INC.7/21/2004 
976-891METOLAZONE TABLETS, USP 10 MG  WATSON LABORATORIES, INC.7/21/2004 
1040-559HYDROXYZINE HYDROCHLORIDE TABLETS, USP 10 MG  ABLE LABORATORIES, INC.7/22/2004 
1140-562HYDROXYZINE HYDROCHLORIDE TABLETS, USP 25 MG  ABLE LABORATORIES, INC.7/22/2004 
1240-563HYDROXYZINE HYDROCHLORIDE TABLETS, USP 50 MG  ABLE LABORATORIES, INC.7/22/2004 
1365-138NYSTATIN TOPICAL POWDER, USP 100,000 UNITS/GRAM  KALI LABORATORIES, INC.7/23/2004 
1476-883SOTALOL HYDROCHLORIDE TABLETS, USP (AF) 80 MG, 120 MG, AND 160 MG  TEVA PHARMACEUTICALS USA7/26/2004 
1540-483BETHANECHOL CHLORIDE TABLETS, USP 10 MG  ABLE LABORATORIES, INC.7/27/2004 
1640-485BETHANECHOL CHLORIDE TABLETS, USP 25 MG  ABLE LABORATORIES, INC.7/27/2004 
1740-492BETHANECHOL CHLORIDE TABLETS, USP 5 MG  ABLE LABORATORIES, INC.7/27/2004 
1840-509BETHANECHOL CHLORIDE TABLETS, USP 50 MG  ABLE LABORATORIES, INC.7/27/2004 
1976-722KETOROLAC TROMETHAMINE INJECTION, USP 15 MG/1 ML, 30 MG/1 ML AND 60 MG/2 ML; PACKAGED IN SINGLE-DOSE SYRINGES  APOTEX CORP.7/27/2004 
2076-493CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION 1%/0.05% (BASE)  TARO PHARMACEUTICALS U.S.A., INC.7/28/2004 
2176-553MEDROXYPROGESTERONE ACETATE INJECTABLE SUSPENSION, USP 150 MG/1 ML SINGLE-DOSE VIALS  SICOR PHARMACEUTICALS, INC.7/28/2004 
2274-681FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG  NOVOPHARM LIMITED7/29/2004 
2376-042FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG  GENPHARM INC.7/29/2004 
2476-077FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG  IVAX PHARMACEUTICALS, INC.7/29/2004 
2576-086FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG  SANDOZ INC.7/29/2004 
2676-087FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML SINGLE-DOSE VIALS.  BEDFORD LABORATORIES7/29/2004 
2776-145FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML SINGLE-DOSE VIALS  AMERICAN PHARMACEUTICAL PARTNERS, INC.7/29/2004 
2876-213FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG  ROXANE LABORATORIES, INC.7/29/2004 
2976-246FLUCONAZOLE FOR ORAL SUSPENSION 10 MG/ML (50 MG/5 ML) AND 40 MG/ML (200 MG/5 ML)  ROXANE LABORATORIES, INC.7/29/2004 
3076-303FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML SINGLE-DOSE PLASTIC CONTAINERS.  HOSPIRA, INC.7/29/2004 
3176-304FLUCONAZOLE INJECTION (IN 5% DEXTROSE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML SINGLE-DOSE PLASTIC CONTAINERS  HOSPIRA, INC.7/29/2004 
3276-332FLUCONAZOLE FOR ORAL SUSPENSION 10 MG/ML (50 MG/5 ML) AND 40 MG/ML (200 MG/5 ML)  RANBAXY LABORATORIES LIMITED7/29/2004 
3376-351FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG  MYLAN PHARMACEUTICALS, INC.7/29/2004 
3476-386FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, 200 MG  RANBAXY LABORATORIES LIMITED7/29/2004 
3576-387CLOTRIMAZOLE LOZENGES, USP 10 MG  ROXANE LABORATORIES, INC.7/29/2004 
3676-424FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG  PLIVA INC.7/29/2004 
3776-432FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG  GEDEON RICHTER LTD.7/29/2004 
3876-507FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG  TARO PHARMACEUTICAL INDUSTRIES, LTD.7/29/2004 
3976-568NICOTINE POLACRILEX GUM, USP (MINT-FLAVORED) (OTC) 4 MG (BASE)  WATSON LABORATORIES, INC.7/29/2004 
4076-569NICOTINE POLACRILEX GUM, USP (MINT FLAVORED) (OTC) 2 MG (BASE)  WATSON LABORATORIES, INC.7/29/2004 
4176-617FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML SINGLE-DOSE PLASTIC CONTAINERS  MAYNE PHARMA (USA) INC.7/29/2004 
4276-653FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML, AND 400 MG/200 ML SINGLE-DOSE VIALS  SICOR PHARMACEUTICALS, INC.7/29/2004 
4376-658FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG  DR. REDDY'S LABORATORIES LIMITED7/29/2004 
4476-665FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG  APOTEX INC.7/29/2004 
4576-730ALCLOMETASONE DIPROPIONATE OINTMENT, USP 0.05%  TARO PHARMACEUTICALS USA, INC.7/29/2004 
4676-766FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML SINGLE-DOSE PLASTIC CONTAINERS  BAXTER HEALTHCARE CORPORATION7/29/2004 
4740-583METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION, USP 40 MG (BASE)/VIAL AND 125 MG (BASE)/VIAL  AMERICAN PHARMACEUTICAL PARTNERS, INC.7/30/2004 
4865-024GENTAMICIN OPHTHALMIC OINTMENT, USP 0.3%  ALTANA INC.7/30/2004 
4976-249METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG  IMPAX LABORATORIES, INC.7/30/2004 
5076-907ATENOLOL TABLETS, USP 25 MG, 50 MG, AND 100 MG  ABLE LABORATORIES, INC.7/30/2004