• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

Approvals - December 2004

 ANDA NumberGeneric Drug NameApplicantApproval Date
176-608FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG AND 20 MG/12.5 MG  ANDRX PHARMACEUTICALS,LLC12/3/2004 
276-624MOMETASONE FUROATE OINTMENT, USP 0.1%  TARO PHARMACEUTICALS USA, INC.12/3/2004 
376-711BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP 200 MG  IMPAX LABORATORIES, INC.12/3/2004 
477-167DIDANOSINE DELAYED-RELEASE CAPSULES 200 MG, 250 MG, AND 400 MG  BARR LABORATORIES, INC.12/3/2004 
577-030CILOSTAZOL TABLETS 50 MG AND 100 MG  APOTEX , INC.12/10/2004 
665-171DEMECLOCYCLINE HYDROCHLORIDE TABLETS, USP 150 MG AND 300 MG  BARR LABORATORIES, INC.12/13/2004 
776-990FLUOXETINE CAPSULES, USP 40 MG  RANBAXY LABORATORIES LIMITED12/13/2004 
877-043CITALOPRAM HYDROBROMIDE ORAL SOLUTION 10 MG (BASE)/ 5 ML  ROXANE LABORATORIES, INC.12/13/2004 
976-223METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG  SANDOZ INC.12/14/2004 
1076-706METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG  APOTEX INC.12/14/2004 
1176-818METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG  COBALT PHARMACEUTICALS, INC.12/14/2004 
1276-873METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG  EON LABS, INC.12/14/2004 
1375-827GABAPENTIN TABLETS 600 MG AND 800 MG  TEVA PHARMACEUTICALS USA12/15/2004 
1476-607QUINAPRIL TABLETS, USP 5 MG, 10 MG, 20 MG, AND 40 MG  RANBAXY LABORATORIES LIMITED12/15/2004 
1540-569PROPOXYPHENE HYDROCHLORIDE CAPSULES, USP 65 MG  MYLAN PHARMACEUTICALS, INC.12/16/2004 
1676-831FLAVOXATE HYDROCHLORIDE TABLETS 100 MG  PADDOCK LABORATORIES, INC.12/16/2004 
1776-872HALOBETASOL PROPIONATE OINTMENT 0.05%  AGIS INDUSTRIES (1983) LTD.12/16/2004 
1876-903HALOBETASOL PROPIONATE OINTMENT 0.05%  ALTANA INC.12/16/2004 
1976-922FLUOXETINE CAPSULES, USP 10 MG, 20 MG, AND 40 MG  PAR PHARMACEUTICAL, INC.12/16/2004 
2076-994HALOBETASOL PROPIONATE OINTMENT 0.05%  TARO PHARMACEUTICALS USA, INC.12/16/2004 
2177-001HALOBETASOL PROPIONATE CREAM 0.05%  ALTANA INC.12/16/2004 
2277-123HALOBETASOL PROPIONATE CREAM 0.05%  AGIS INDUSTRIES (1983) LTD.12/16/2004 
2365-175NYSTATIN TOPICAL POWDER, USP 100,000 UNITS/GRAM  X-GEN PHARMACEUTICALS, INC.12/17/2004 
2476-574ECONAZOLE NITRATE CREAM 1%  HEALTHPOINT, LTD.12/17/2004 
2576-739FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG AND 20 MG/12.5 MG  RANBAXY LABORATORIES LIMITED12/17/2004 
2675-317TERAZOSIN HYDROCHLORIDE CAPSULES 1 MG (BASE), 2 MG (BASE), 5 MG (BASE), AND 10 MG (BASE)  TRIGEN LABORATORIES, INC.12/20/2004 
2740-581PREDNISONE TABLETS, USP 2.5 MG  VINTAGE PHARMACEUTICALS, INC.12/21/2004 
2840-584PREDNISONE TABLETS, USP 1 MG  VINTAGE PHARMACEUTICALS, INC.12/21/2004 
2976-679MOMETASONE FUROATE CREAM, USP 0.1%  TARO PHARMACEUTICALS U.S.A., INC.12/21/2004 
3040-568GLYCOPYRROLATE TABLETS, USP 1 MG AND 2 MG  COREPHARMA LLC12/22/2004 
3176-459QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  AMIDE PHARMACEUTICAL, INC.12/22/2004 
3276-963PILOCARPINE HYDROCHLORIDE TABLETS 5 MG  ROXANE LABORATORIES, INC.12/22/2004 
3376-694QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE)  MYLAN PHARMACEUTICALS, INC.12/23/2004 
3476-855HYDROMORPHONE HYDROCHLORIDE TABLETS, USP 8 MG  MALLINCKRODT, INC.12/23/2004 
3576-987FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG AND 40 MG  WATSON LABORATORIES, INC.12/23/2004 
3665-139CLINDAMYCIN PHOSPHATE VAGINAL CREAM, USP 2% (BASE)  ALTANA INC.12/27/2004 
3776-842HYDROCORTISONE BUTYRATE OINTMENT, USP 0.1%  TARO PHARMACEUTICAL INDUSTRIES LTD.12/27/2004 
3840-600HYDROXYZINE HYDROCHLORIDE TABLETS, USP 10 MG  AMIDE PHARMACEUTICAL, INC.12/28/2004 
3940-602HYDROXYZINE HYDROCHLORIDE TABLETS, USP 25 MG  AMIDE PHARMACEUTICAL, INC.12/28/2004 
4040-604HYDROXYZINE HYDROCHLORIDE TABLETS, USP 50 MG  AMIDE PHARMACEUTICAL, INC.12/28/2004 
4176-682OXYBUTYNIN CHLORIDE SYRUP, USP 5 MG/5 ML  VINTAGE PHARMACEUTICALS, LLC12/28/2004 
4276-435CICLOPIROX OLAMINE CREAM, USP 0.77%  ALTANA INC.12/29/2004