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U.S. Department of Health and Human Services

Drugs

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Approvals - February 2006

 ANDA NumberGeneric Drug NameApplicantApproval Date
176-395DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES USP, 120 MG, 180 MG, 240 MG, 300 MG, AND 360 MG (ONCE-A-DAY DOSAGE)  APOTEX INC.2/1/2006 
276-820BENAZEPRIL HYDROCHLORIDE TABLETS, 5 MG, 10 MG, 20 MG, AND 40 MG  BIOKEY, INC.2/3/2006 
377-280GLIMEPIRIDE TABLETS, 1 MG, 2 MG, AND 4 MG  COBALT PHARMACEUTICALS, INC.2/3/2006 
477-291CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP, 5 MG  AMIDE PHARMACEUTICAL, INC.2/3/2006 
540-609HYDROCORTISONE AND ACETIC ACID OTIC SOLUTION USP, 1%/2%  VINTAGE PHARMACEUTICALS, LLC2/6/2006 
665-311CEFADROXIL CAPSULES USP, 500 MG  HIKMA PHARMACEUTICALS2/7/2006 
776-829AMMONIUM LACTATE CREAM, 12% (AS LACTIC ACID)  PADDOCK LABORATORIES, INC.2/7/2006 
877-102CALCITRIOL INJECTION, 0.001 MG/ML (1 MCG/ML); 1 ML VIALS  GENIX THERAPEUTICS, INC.2/8/2006 
977-336METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 500 MG AND 750 MG  SUN PHARMACEUTICAL INDUSTRIES, LTD.2/9/2006 
1077-098OFLOXACIN TABLETS, 200 MG, 300 MG, AND 400 MG  DR. REDDY'S LABORATORIES LIMITED2/10/2006 
1177-450OCTREOTIDE ACETATE INJECTION, 0.2 MG(BASE)/ML AND 1 MG(BASE)/ML; 5 ML VIALS  AMERICAN PHARMACEUTICAL PARTNERS, INC.2/10/2006 
1277-457OCTREOTIDE ACETATE INJECTION, 0.05 MG(BASE)/ML, 0.1 MG(BASE)/ML, AND 0.5 MG (BASE)/ML; 1 ML VIALS (PRESERVATIVE-FREE)  AMERICAN PHARMACEUTICAL PARTNERS, INC.2/10/2006 
1377-486GLIMEPIRIDE TABLETS, 1 MG, 2 MG, AND 4 MG  GENPHARM INC.2/10/2006 
1465-312CEFOXITIN FOR INJECTION USP, 10 G/VIAL (PHARMACY BULK PACKAGE)  ORCHID HEALTHCARE2/13/2006 
1540-649PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HBR SYRUP 6.25 MG/15 MG PER 5 ML  VINTAGE PHARMACEUTICALS, LLC2/14/2006 
1665-254CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION USP, (PLEDGETS) 1%  ALTANA, INC.2/14/2006 
1776-471LORATADINE TABLETS USP, (OTC) 10 MG  APOTEX INC.2/14/2006 
1865-245CEFTRIAXONE FOR INJECTION USP, 250 MG/VIAL, 500 MG/VIAL, 1 G/VIAL, AND 2 G/VIAL  AMERICAN PHARMACEUTICAL PARTNERS, INC.2/15/2006 
1965-252CEFTRIAXONE FOR INJECTION USP, 10 GRAMS/VIAL (PHARMACY BULK PACKAGE)  AMERICAN PHARMACEUTICAL PARTNERS, INC.2/15/2006 
2077-266CARBOPLATIN INJECTION, 10 MG/ML; 5 ML, 15 ML, 45 ML, AND 60 ML VIALS  AMERICAN PHARMACEUTICAL PARTNERS, INC.2/15/2006 
2177-404MEGESTROL ACETATE ORAL SUSPENSION USP, 40 MG/ML  APOTEX INC.2/16/2006 
2277-458RANITIDINE INJECTION USP, 25 MG/ML; 40 ML VIAL (PHARMACY BULK PACKAGE)  BEDFORD LABORATORIES2/16/2006 
2376-504FLUTICASONE PROPIONATE NASAL SPRAY, 0.05 MG (50 MCG)/ SPRAY  ROXANE LABORATORIES, INC.2/22/2006 
2477-622LISINOPRIL TABLETS USP, 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG  AUROBINDO PHARMA LIMITED2/22/2006 
2575-900FLUVOXAMINE MALEATE TABLETS 25 MG, 50 MG, AND 100 MG  CARACO PHARMACEUTICAL LABORATORIES, LTD.2/23/2006 
2677-659AMANTADINE HYDROCHLORIDE CAPSULES USP, 100 MG  AMIDE PHARMACEUTICAL, INC.2/23/2006 
2776-760RANITIDINE TABLETS USP, (OTC) 75 MG  WOCKHARDT LIMITED2/24/2006 
2865-287DOXYCYCLINE HYCLATE TABLETS USP, 20 MG (BASE)  PAR PHARMACEUTICAL2/28/2006