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U.S. Department of Health and Human Services

Drugs

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Approvals - May 2005

 ANDA NumberGeneric Drug NameApplicantApproval Date
176-379MIDAZOLAM HYDROCHLORIDE SYRUP, 2 MG (BASE)/ML  PADDOCK LABORATORIES, INC.5/2/2005 
276-474ESMOLOL HYDROCHLORIDE INJECTION 10 MG/ML; 10 ML VIALS  PHARMAFORCE, INC.5/2/2005 
376-573ESMOLOL HYDROCHLORIDE INJECTION 10 MG/ML; 10 ML VIALS  AMERICAN PHARMACEUTICAL PARTNERS, INC.5/2/2005 
477-147CLONAZEPAM TABLETS USP 0.5 MG, 1 MG, AND 2 MG  KALI LABORATORIES, INC.5/2/2005 
565-183NYSTATIN TOPICAL POWDER USP, 100,000 UNITS/GRAM  UPSHER-SMITH LABORATORIES, INC.5/3/2005 
665-204CEFTRIAXONE FOR INJECTION USP, 1 G AND 2 G VIALS  SANDOZ, INC.5/3/2005 
777-071FLUMAZENIL INJECTION USP, 0.1 MG/ML; 5 ML AND 10 ML VIALS  SABEX 2002 INC.5/3/2005 
865-169CEFTRIAXONE FOR INJECTION USP, 250 MG, 500 MG, 1 G, AND 2 G VIALS  SANDOZ, INC.5/9/2005 
976-291IPRATROPIUM BROMIDE INHALATION SOLUTION, 0.02%; 0.5 MG/2.5 ML VIALS  BREATH LIMITED5/9/2005 
1065-103DOXYCYCLINE HYCLATE CAPSULES USP, 20 MG  WEST-WARD PHARMACEUTICAL CORP.5/13/2005 
1165-134DOXYCYCLINE HYCLATE TABLETS USP, 20 MG  MUTUAL PHARMACEUTICAL COMPANY, INC.5/13/2005 
1265-163DOXYCYCLINE HYCLATE TABLETS USP, 20 MG  IVAX PHARMACEUTICALS, INC.5/13/2005 
1365-182DOXYCYCLINE HYCLATE TABLETS USP, 20 MG  COREPHARMA LLC5/13/2005 
1476-433FENOFIBRATE TABLETS, 54 MG AND 160 MG  TEVA PHARMACEUTICALS USA5/13/2005 
1565-168CEFTRIAXONE FOR INJECTION USP, 10 G/VIAL (PHARMACY BULK PACKAGE)  SANDOZ, INC.5/17/2005 
1676-906FOSINOPRIL SODIUM TABLETS, 10 MG, 20 MG, AND 40 MG  APOTEX INC.5/17/2005 
1777-024CILOSTAZOL TABLETS, 50 MG AND 100 MG  ROXANE LABORATORIES, INC.5/17/2005 
1865-154CLARITHROMYCIN EXTENDED-RELEASE TABLETS, 500 MG  TEVA PHARMACEUTICALS USA5/18/2005 
1976-251FLUOXETINE CAPSULES USP, 40 MG  BARR LABORATORIES, INC.5/18/2005 
2077-077NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP, AND FERROUS FUMARATE TABLETS, 1 MG/0.02 MG/75 MG  ANDRX PHARMACEUTICALS, LLC5/20/2005 
2176-785ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL TABLETS USP, 1 MG/35 MCG; PACKAGED IN 28-DAY REGIMENS  BARR LABORATORIES, INC.5/23/2005 
2276-982PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION, 5 MG (BASE)/5 ML  KV PHARMACEUTICAL COMPANY5/24/2005 
2376-988PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION, 15 MG (BASE)/5 ML  KV PHARMACEUTICAL COMPANY5/24/2005 
2440-574HYDROXYZINE HYDROCHLORIDE TABLETS USP, 25 MG  VINTAGE PHARMACEUTICALS, LLC5/27/2005 
2540-579HYDROXYZINE HYDROCHLORIDE TABLETS USP, 10 MG  VINTAGE PHARMACEUTICALS, LLC5/27/2005 
2640-580HYDROXYZINE HYDROCHLORIDE TABLETS USP, 50 MG  VINTAGE PHARMACEUTICALS, LLC5/27/2005 
2765-137CLARITHROMYCIN TABLETS USP, 250 MG AND 500 MG  IVAX PHARMACEUTICALS, INC.5/31/2005 
2865-155CLARITHROMYCIN TABLETS USP, 250 MG AND 500 MG  TEVA PHARMACEUTICALS USA5/31/2005 
2976-894TORSEMIDE TABLETS, 5 MG, 10 MG, 20 MG, AND 100 MG  APOTEX INC.5/31/2005 
3077-174FOSCARNET SODIUM INJECTION, 24 MG/ML; 250 ML AND 500 ML BOTTLES  PHARMAFORCE, INC.5/31/2005