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U.S. Department of Health and Human Services

Drugs

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Approvals - June 2006

  ANDA Number Generic Drug Name Applicant Approval Date
1 77-880 METFORMIN HYDROCHLORIDE TABLETS USP, 500 MG, 850 MG, AND 1000 MG   INTERPHARM, INC. 6/5/2006 
2 77-018 METRONIDAZOLE TOPICAL GEL, 0.75%   ALTANA INC. 6/6/2006 
3 77-440 POTASSIUM CITRATE EXTENDED-RELEASE TABLETS USP, 5 mEq AND 10 mEq   COREPHARMA, LLC 6/8/2006 
4 40-671 TRIAMCINOLONE ACETONIDE CREAM USP, 0.025% AND 0.1%   VINTAGE PHARMACEUTICALS, LLC 6/9/2006 
5 40-575 TESTOSTERONE ENANTHATE INJECTION USP, 200 MG/ML; 5 ML MULTIPLE-DOSE VIALS   PADDOCK LABORATORIES, INC. 6/14/2006 
6 77-629 CITALOPRAM HYDROBROMIDE ORAL SOLUTION, 10 MG (BASE)/5 ML   SILARX PHARMACEUTICALS, INC. 6/14/2006 
7 65-322 AMOXICILLIN FOR ORAL SUSPENSION USP, 125 MG/5 ML AND 250 MG/5 ML   HIKMA PHARMACEUTICALS 6/19/2006 
8 65-325 AMOXICILLIN FOR ORAL SUSPENSION USP, 200 MG/5 ML AND 400 MG/5 ML   HIKMA PHARMACEUTICALS 6/19/2006 
9 76-340 FINASTERIDE TABLETS USP, 5 MG   IVAX PHARMACEUTICALS, INC. 6/19/2006 
10 77-401 MOMETASONE FUROATE OINTMENT USP, 0.1%   G & W LABORATORIES, INC. 6/20/2006 
11 77-690 QUINAPRIL TABLETS USP, 5 MG, 10 MG, 20 MG, AND 40 MG   LUPIN LIMITED 6/20/2006 
12 77-965 NORTRIPTYLINE HYDROCHLORIDE ORAL SOLUTION USP, 10 MG (BASE)/5 ML   TARO PHARMACEUTICAL INDUSTRIES, LTD. 6/20/2006 
13 76-420 LAMOTRIGINE TABLETS, (CHEWABLE) 5 MG AND 25 MG   TEVA PHARMACEUTICALS USA 6/21/2006 
14 76-052 SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, AND 40 MG   IVAX PHARMACEUTICALS, INC. 6/23/2006 
15 76-285 SIMVASTATIN TABLETS USP, 80 MG   RANBAXY INC. 6/23/2006 
16 77-613 ANAGRELIDE HYDROCHLORIDE CAPSULES, 0.5 MG (BASE) AND 1 MG (BASE)   ALPHAPHARM PTY, LTD. 6/27/2006 
17 40-668 CYPROHEPTADINE HYDROCHLORIDE SYRUP USP, 2 MG/5 ML   LYNE LABORATORIES 6/28/2006 
18 77-856 CLONAZEPAM TABLETS USP, 0.5 MG, 1 MG, AND 2 MG   VINTAGE PHARMACEUTICALS, LLC 6/28/2006 
19 40-640 TRANYLCYPROMINE SULFATE TABLETS, 10 MG (BASE)   KALI LABORATORIES, INC. 6/29/2006 
20 65-262 CEFTRIAXONE FOR INJECTION USP, 1 G/100 ML AND 2 G/100 ML   TEVA PHARMACEUTICALS USA 6/29/2006 
21 77-421 LORATADINE ORAL SOLUTION USP, (OTC) 5 MG/5 ML   SILARX PHARMACEUTICALS, INC. 6/29/2006 
22 65-202 CEFPROZIL FOR ORAL SUSPENSION USP, 125 MG/5 ML AND 250 MG/5 ML   RANBAXY LABORATORIES LIMITED 6/30/2006 
23 75-719 SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE)   IVAX PHARMACEUTICALS, INC. 6/30/2006 
24 76-934 SERTRALINE HYDROCHLORIDE ORAL CONCENTRATE, 20 MG (BASE)/ML   ROXANE LABORATORIES, INC. 6/30/2006 
25 77-055 FLUTICASONE PROPIONATE CREAM, 0.05%   G & W LABORATORIES, INC. 6/30/2006 
26 77-777 ALPRAZOLAM EXTENDED-RELEASE TABLETS, 0.5 MG, 1 MG, 2 MG, AND 3 MG   SANDOZ INC. 6/30/2006 

 

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