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U.S. Department of Health and Human Services

Drugs

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Approvals - June 2006

 ANDA NumberGeneric Drug NameApplicantApproval Date
177-880METFORMIN HYDROCHLORIDE TABLETS USP, 500 MG, 850 MG, AND 1000 MG  INTERPHARM, INC.6/5/2006 
277-018METRONIDAZOLE TOPICAL GEL, 0.75%  ALTANA INC.6/6/2006 
377-440POTASSIUM CITRATE EXTENDED-RELEASE TABLETS USP, 5 mEq AND 10 mEq  COREPHARMA, LLC6/8/2006 
440-671TRIAMCINOLONE ACETONIDE CREAM USP, 0.025% AND 0.1%  VINTAGE PHARMACEUTICALS, LLC6/9/2006 
540-575TESTOSTERONE ENANTHATE INJECTION USP, 200 MG/ML; 5 ML MULTIPLE-DOSE VIALS  PADDOCK LABORATORIES, INC.6/14/2006 
677-629CITALOPRAM HYDROBROMIDE ORAL SOLUTION, 10 MG (BASE)/5 ML  SILARX PHARMACEUTICALS, INC.6/14/2006 
765-322AMOXICILLIN FOR ORAL SUSPENSION USP, 125 MG/5 ML AND 250 MG/5 ML  HIKMA PHARMACEUTICALS6/19/2006 
865-325AMOXICILLIN FOR ORAL SUSPENSION USP, 200 MG/5 ML AND 400 MG/5 ML  HIKMA PHARMACEUTICALS6/19/2006 
976-340FINASTERIDE TABLETS USP, 5 MG  IVAX PHARMACEUTICALS, INC.6/19/2006 
1077-401MOMETASONE FUROATE OINTMENT USP, 0.1%  G & W LABORATORIES, INC.6/20/2006 
1177-690QUINAPRIL TABLETS USP, 5 MG, 10 MG, 20 MG, AND 40 MG  LUPIN LIMITED6/20/2006 
1277-965NORTRIPTYLINE HYDROCHLORIDE ORAL SOLUTION USP, 10 MG (BASE)/5 ML  TARO PHARMACEUTICAL INDUSTRIES, LTD.6/20/2006 
1376-420LAMOTRIGINE TABLETS, (CHEWABLE) 5 MG AND 25 MG  TEVA PHARMACEUTICALS USA6/21/2006 
1476-052SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, AND 40 MG  IVAX PHARMACEUTICALS, INC.6/23/2006 
1576-285SIMVASTATIN TABLETS USP, 80 MG  RANBAXY INC.6/23/2006 
1677-613ANAGRELIDE HYDROCHLORIDE CAPSULES, 0.5 MG (BASE) AND 1 MG (BASE)  ALPHAPHARM PTY, LTD.6/27/2006 
1740-668CYPROHEPTADINE HYDROCHLORIDE SYRUP USP, 2 MG/5 ML  LYNE LABORATORIES6/28/2006 
1877-856CLONAZEPAM TABLETS USP, 0.5 MG, 1 MG, AND 2 MG  VINTAGE PHARMACEUTICALS, LLC6/28/2006 
1940-640TRANYLCYPROMINE SULFATE TABLETS, 10 MG (BASE)  KALI LABORATORIES, INC.6/29/2006 
2065-262CEFTRIAXONE FOR INJECTION USP, 1 G/100 ML AND 2 G/100 ML  TEVA PHARMACEUTICALS USA6/29/2006 
2177-421LORATADINE ORAL SOLUTION USP, (OTC) 5 MG/5 ML  SILARX PHARMACEUTICALS, INC.6/29/2006 
2265-202CEFPROZIL FOR ORAL SUSPENSION USP, 125 MG/5 ML AND 250 MG/5 ML  RANBAXY LABORATORIES LIMITED6/30/2006 
2375-719SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)  IVAX PHARMACEUTICALS, INC.6/30/2006 
2476-934SERTRALINE HYDROCHLORIDE ORAL CONCENTRATE, 20 MG (BASE)/ML  ROXANE LABORATORIES, INC.6/30/2006 
2577-055FLUTICASONE PROPIONATE CREAM, 0.05%  G & W LABORATORIES, INC.6/30/2006 
2677-777ALPRAZOLAM EXTENDED-RELEASE TABLETS, 0.5 MG, 1 MG, 2 MG, AND 3 MG  SANDOZ INC.6/30/2006