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U.S. Department of Health and Human Services

Drugs

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Approvals - February 2006

  ANDA Number Generic Drug Name Applicant Approval Date
1 76-395 DILTIAZEM 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 
2 76-820 BENAZEPRIL HYDROCHLORIDE TABLETS, 5 MG, 10 MG, 20 MG, AND 40 MG   BIOKEY, INC. 2/3/2006 
3 77-280 GLIMEPIRIDE TABLETS, 1 MG, 2 MG, AND 4 MG   COBALT PHARMACEUTICALS, INC. 2/3/2006 
4 77-291 CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP, 5 MG   AMIDE PHARMACEUTICAL, INC. 2/3/2006 
5 40-609 HYDROCORTISONE AND ACETIC ACID OTIC SOLUTION USP, 1%/2%   VINTAGE PHARMACEUTICALS, LLC 2/6/2006 
6 65-311 CEFADROXIL CAPSULES USP, 500 MG   HIKMA PHARMACEUTICALS 2/7/2006 
7 76-829 AMMONIUM LACTATE CREAM, 12% (AS LACTIC ACID)   PADDOCK LABORATORIES, INC. 2/7/2006 
8 77-102 CALCITRIOL INJECTION, 0.001 MG/ML (1 MCG/ML); 1 ML VIALS   GENIX THERAPEUTICS, INC. 2/8/2006 
9 77-336 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 500 MG AND 750 MG   SUN PHARMACEUTICAL INDUSTRIES, LTD. 2/9/2006 
10 77-098 OFLOXACIN TABLETS, 200 MG, 300 MG, AND 400 MG   DR. REDDY'S LABORATORIES LIMITED 2/10/2006 
11 77-450 OCTREOTIDE ACETATE INJECTION, 0.2 MG(BASE)/ML AND 1 MG(BASE)/ML; 5 ML VIALS   AMERICAN PHARMACEUTICAL PARTNERS, INC. 2/10/2006 
12 77-457 OCTREOTIDE 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 
13 77-486 GLIMEPIRIDE TABLETS, 1 MG, 2 MG, AND 4 MG   GENPHARM INC. 2/10/2006 
14 65-312 CEFOXITIN FOR INJECTION USP, 10 G/VIAL (PHARMACY BULK PACKAGE)   ORCHID HEALTHCARE 2/13/2006 
15 40-649 PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HBR SYRUP 6.25 MG/15 MG PER 5 ML   VINTAGE PHARMACEUTICALS, LLC 2/14/2006 
16 65-254 CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION USP, (PLEDGETS) 1%   ALTANA, INC. 2/14/2006 
17 76-471 LORATADINE TABLETS USP, (OTC) 10 MG   APOTEX INC. 2/14/2006 
18 65-245 CEFTRIAXONE FOR INJECTION USP, 250 MG/VIAL, 500 MG/VIAL, 1 G/VIAL, AND 2 G/VIAL   AMERICAN PHARMACEUTICAL PARTNERS, INC. 2/15/2006 
19 65-252 CEFTRIAXONE FOR INJECTION USP, 10 GRAMS/VIAL (PHARMACY BULK PACKAGE)   AMERICAN PHARMACEUTICAL PARTNERS, INC. 2/15/2006 
20 77-266 CARBOPLATIN INJECTION, 10 MG/ML; 5 ML, 15 ML, 45 ML, AND 60 ML VIALS   AMERICAN PHARMACEUTICAL PARTNERS, INC. 2/15/2006 
21 77-404 MEGESTROL ACETATE ORAL SUSPENSION USP, 40 MG/ML   APOTEX INC. 2/16/2006 
22 77-458 RANITIDINE INJECTION USP, 25 MG/ML; 40 ML VIAL (PHARMACY BULK PACKAGE)   BEDFORD LABORATORIES 2/16/2006 
23 76-504 FLUTICASONE PROPIONATE NASAL SPRAY, 0.05 MG (50 MCG)/ SPRAY   ROXANE LABORATORIES, INC. 2/22/2006 
24 77-622 LISINOPRIL TABLETS USP, 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG   AUROBINDO PHARMA LIMITED 2/22/2006 
25 75-900 FLUVOXAMINE MALEATE TABLETS 25 MG, 50 MG, AND 100 MG   CARACO PHARMACEUTICAL LABORATORIES, LTD. 2/23/2006 
26 77-659 AMANTADINE HYDROCHLORIDE CAPSULES USP, 100 MG   AMIDE PHARMACEUTICAL, INC. 2/23/2006 
27 76-760 RANITIDINE TABLETS USP, (OTC) 75 MG   WOCKHARDT LIMITED 2/24/2006 
28 65-287 DOXYCYCLINE HYCLATE TABLETS USP, 20 MG (BASE)   PAR PHARMACEUTICAL 2/28/2006 

 

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