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U.S. Department of Health and Human Services

Drugs

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Approvals - April 2005

 ANDA NumberGeneric Drug NameApplicantApproval Date
177-226BROMOCRIPTINE MESYLATE CAPSULES, USP 5 MG (BASE)  MYLAN PHARMACEUTICALS, INC.4/4/2005 
277-066NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES 100 MG  EON LABS, INC.4/5/2005 
375-360GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG  APOTEX INC.4/6/2005 
475-539GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG  EON PHARMA, LLC4/6/2005 
577-180MOMETASONE FUROATE TOPICAL SOLUTION, USP 0.1%  AIGIS INDUSTRIES LTD.4/6/2005 
676-171MOMETASONE FUROATE CREAM, USP 0.1%  ALTANA INC.4/8/2005 
776-330OCTREOTIDE ACETATE INJECTION 0.2 MG/ML (BASE) 1 MG/ML (BASE)  BEDFORD LABORATORIES4/8/2005 
877-069AMIODARONE HYDROCHLORIDE TABLETS 200 MG 400 MG  AUROSAL PHARMACEUTICALS, LLC.4/8/2005 
976-942KETOCONAZOLE SHAMPOO 2 %  QLT USA, INC.4/11/2005 
1076-790CICLOPIROX OLAMINE CREAM, USP 0.77%  TARO PHARMACEUTICALS USA, INC.4/12/2005 
1176-864METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 750 MG  TEVA PHARMACEUTICALS USA4/12/2005 
1276-869METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 750 MG  ANDRX PHARMACEUTICALS, LLC4/12/2005 
1376-878METFORMIN HYDROCHLORIDE EXTENDED-REAEASE 750 MG  PUREPAC PHARMACEUTICAL CO4/13/2005 
1476-236FEXOFENADINE HCL & PSEUDOEPHEDRINE HCL EXTENDED-RELEASE TAB 60 MG/120 MG  BARR LABORATORIES, INC.4/14/2005 
1576-250NIACIN EXTENDED-RELEASE TABLETS 1000 MG  BARR LABORATORIES, INC.4/14/2005 
1640-555PHENTERMINE HYDROCHLORIDE TABLETS, USP 37.5 MG  LANNETT HOLDINGS, INC.4/15/2005 
1776-417ANAGRELIDE HYDROCHLORIDE CAPSULES 0.5 MG (BASE) AND 1 MG (BASE)  WATSON LABORATORIES, INC.4/18/2005 
1876-468ANAGRELIDE HYDROCHLORIDE CAPSULES 0.5 MG (BASE) AND 1 MG (BASE)  IVAX PHARMACEUTICALS, INC.4/18/2005 
1976-489ANAGRELIDE HYDROCHLORIDE CAPSULES 0.5 MG (BASE) AND 1 MG (BASE)  ROXANE LABORATORIES, INC.4/18/2005 
2076-530ANAGRELIDE HYDROCHLORIDE CAPSULES 0.5 MG (BASE) AND 1 MG (BASE)  BARR LABORATORIES, INC.4/18/2005 
2176-683ANAGRELIDE HYDROCHLORIDE CAPSULES 0.5 MG (BASE) AND 1 MG (BASE)  EON LABS, INC.4/18/2005 
2276-811ANAGRELIDE HYDROCHLORIDE CAPSULES 0.5 MG (BASE) AND 1 MG (BASE)  MYLAN PHARMACEUTICALS, INC.4/18/2005 
2376-849VINORELBINE TARTRATE INJECTION 10 MG (BASE)/ML; PACKAGED IN 10 MG (BASE)/1 ML AND 50 MG (BASE)/5 ML SINGLE-USE VIALS  AMERICAN PHARMACEUTICAL PARTNERS, INC.4/18/2005 
2476-910ANAGRELIDE HYDROCHLORIDE CAPSULES 0.5 MG (BASE) AND 1 MG (BASE)  IMPAX LABORATORIES, INC.4/18/2005 
2577-064METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1000 MG  ZYDUS PHARMACEUTICALS USA, INC.4/18/2005 
2674-848PROPOFOL INJECTABLE EMULSION 10 MG/ML; PACKAGED IN 20 ML, 50 ML, AND 100 ML SINGLE-DOSE VIALS  BEDFORD LABORATORIES4/19/2005 
2777-060METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG  ZYDUS PHARMACEUTICALS USA INC.4/20/2005 
2877-161AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML  APOTEX CORP.4/20/2005 
2977-222FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG, AND 40 MG  INVAGEN PHARMACEUTICALS, INC.4/20/2005 
3065-226CEFAZOLIN FOR INJECTION, USP 500 MG/VIAL AND 1 G/VIAL  ORCHID HEALTHCARE4/21/2005 
3176-475TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS 37.5 MG/325 MG  KALI LABORATORIES, INC.4/21/2005 
3277-078METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 750 MG  ZYDUS PHARMACEUTICALS USA, INC.4/21/2005 
3340-572DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP 10 MG/ML (AS DEXAMETHASONE PHOSPHATE) (PRESERVED) MULTIPLE-DOSE VIALS  AMERICAN PHARMACEUTICAL PARTNERS, INC.4/22/2005 
3476-913PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 15 MG (BASE)/5 ML  PHARMACEUTICAL ASSOCIATES, INC.4/25/2005 
3575-162CLOZAPINE TABLETS, USP 25 MG AND 100 MG  TEVA PHARMACEUTICALS USA4/26/2005 
3676-378NIACIN EXTENDED-RELEASE TABLETS 500 MG AND 750 MG  BARR LABORATORIES, INC.4/26/2005 
3777-133ADENOSINE INJECTION, USP 3 MG/ML; PACKAGED IN 6 MG/2 ML AND 12 MG/4 ML SINGLE-USE VIALS  AMERICAN PHARMACEUTICAL PARTNERS, INC.4/27/2005 
3877-339NAPROXEN TABLETS, USP 250 MG, 375 MG, AND 500 MG  PERRIGO R&D COMPANY4/27/2005 
3977-075NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP AND FERROUS FUMARATE TABLETS 1.5 MG/0.03 MG/75 MG  ANDRX PHARMACEUTICALS, LLC4/28/2005 
4076-812ESTRADIOL AND ESTRADIOL/NORGESTIMATE TABLETS 1 MG AND 1 MG/0.09 MG  BARR LABORATORIES, INC.4/29/2005 
4177-045CITALOPRAM HYDROBROMIDE TABLETS 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  AKYMA PHARMACEUTICALS, LLC4/29/2005