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U.S. Department of Health and Human Services

Drugs

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Approvals - July 2005

 Approvals - July 2005

 ANDA NumberGeneric Drug NameApplicantApproval Date
140-594MERCAPTOPURINE TABLETS USP, 50 MG  MYLAN PHARMACEUTICALS, INC.7/1/2005 
276-470DESMOPRESSIN ACETATE TABLETS, 0.1 MG AND 0.2 MG  BARR LABORATORIES, INC.7/1/2005 
340-648ISONIAZID INJECTION USP, 100 MG/ML; PACKAGED IN 10 ML MULTIPLE-DOSE VIALS  SABEX 2002 INC.7/5/2005 
440-498DIPHENHYDRAMINE HYDROCHLORIDE INJECTION USP, 50 MG/ML; PACKAGED IN 10 ML MULTIPLE-DOSE VIALS  BIONICHE PHARMA7/12/2005 
540-619METHIMAZOLE TABLETS USP, 15 MG  CEDAR PHARMACEUTICALS LLC7/12/2005 
676-973ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05%  ALTANA INC.7/12/2005 
777-142METHADONE HYDROCHLORIDE TABLETS USP, (DISKETS, DISPERSIBLE T 40 MG  MALLINCKRODT INC.7/12/2005 
865-228AMOXICILLIN TABLETS USP, 500 MG AND 875 MG  SANDOZ INC.7/13/2005 
976-169FEXOFENADINE HYDROCHLORIDE CAPSULES 60 MG  BARR LABORATORIES, INC.7/13/2005 
1077-005HYDROCHLOROTHIAZIDE CAPSULES 12.5 MG  IVAX PHARMACEUTICALS, INC.7/13/2005 
1177-074LORAZEPAM INJECTION USP (PRESERVATIVE-FREE), 2 MG/ML AND 4 MG/ML; PACKAGED IN 1 ML SINGLE-DOSE VIALS  BEDFORD LABORATORIES7/13/2005 
1277-076LORAZEPAM INJECTION USP, 2 MG/ML AND 4 MG/ML; PACKAGED IN 10 ML MULTIPLE-DOSE VIALS  BEDFORD LABORATORIES7/13/2005 
1376-834BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP, 150 MG (RLD=ZYBAN/GSK)  SANDOZ INC.7/14/2005 
1476-845BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP, 100 MG AND 150 MG  SANDOZ INC.7/14/2005 
1540-582FOLIC ACID TABLETS USP, 1 MG  MUTUAL PHARMACEUTICAL COMPANY, INC.7/18/2005 
1676-884ALCLOMETASONE DIPROPIONATE OINTMENT USP, 0.05%  ALTANA INC.7/18/2005 
1777-114IBUPROFEN TABLETS USP, 400 MG, 600 MG, AND 800 MG  PERRIGO R&D COMPANY7/18/2005 
1877-072IPRATROPIUM BROMIDE INHALATION SOLUTION 0.02%; PACKAGED IN 0.5 MG/2.5 ML UNIT-DOSE VIALS  RxELITE7/19/2005 
1977-151MILRINONE LACTATE IN 5% DEXTROSE INJECTION 20 MG (BASE)/100 ML; PACKAGED IN 20 MG (BASE)/100 ML AND 40 MG (BASE)/200 ML FLEXIBLE PLASTIC CONTAINERS  APOTEX CORP.7/20/2005 
2040-625FOLIC ACID TABLETS USP, 1 MG  PHARMAX GROUP, INC.7/21/2005 
2176-705RANITIDINE TABLETS USP, 150 MG AND 300 MG  DR. REDDY'S LABORATORIES LIMITED7/27/2005 
2277-352FAMOTIDINE TABLETS USP, 20 MG AND 40 MG  PERRIGO R&D COMPANY7/27/2005 
2340-601BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLETS USP, 50 MG/325 MG/40 MG  MUTUAL PHARMACEUTICAL COMPANY, INC.7/29/2005 
2465-166CEFUROXIME AXETIL TABLETS USP, 125 MG (BASE), 250 MG (BASE), AND 500 MG (BASE)  WOCKHARDT LIMITED7/29/2005 
2565-221RIFAMPIN AND ISONIAZID CAPSULES USP, 300 MG/150 MG  WEST-WARD PHARMACEUTICAL CORP.7/29/2005 
2676-915DESOGESTREL AND ETHINYL ESTRADIOL TABLETS 0.15 MG/0.03 MG; PACKAGED IN 28-DAY CYCLES  WATSON LABORATORIES, INC.7/29/2005 
2777-105VALPROIC ACID SYRUP USP, 250 MG/5 ML  APOTEX INC.7/29/2005 
2877-121BACLOFEN TABLETS USP, 20 MG  ALPHAPHARM PTY. LTD.7/29/2005 
2977-181BACLOFEN TABLETS USP, 10 MG  ALPHAPHARM PTY. LTD.7/29/2005