Generic Approvals - December 2004

ANDA Number Generic Drug Name Applicant Approval Date

1 76-608 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG AND 20 MG/12.5 MG ANDRX PHARMACEUTICALS,LLC 12/3/2004

2 76-624 MOMETASONE FUROATE OINTMENT, USP 0.1% TARO PHARMACEUTICALS USA, INC. 12/3/2004

3 76-711 BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, USP 200 MG IMPAX LABORATORIES, INC. 12/3/2004

4 77-167 DIDANOSINE DELAYED-RELEASE CAPSULES 200 MG, 250 MG, AND 400 MG BARR LABORATORIES, INC. 12/3/2004

5 77-030 CILOSTAZOL TABLETS 50 MG AND 100 MG APOTEX , INC. 12/10/2004

6 65-171 DEMECLOCYCLINE HYDROCHLORIDE TABLETS, USP 150 MG AND 300 MG BARR LABORATORIES, INC. 12/13/2004

7 76-990 FLUOXETINE CAPSULES, USP 40 MG RANBAXY LABORATORIES LIMITED 12/13/2004

8 77-043 CITALOPRAM HYDROBROMIDE ORAL SOLUTION 10 MG (BASE)/ 5 ML ROXANE LABORATORIES, INC. 12/13/2004

9 76-223 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG SANDOZ INC. 12/14/2004

10 76-706 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG APOTEX INC. 12/14/2004

11 76-818 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG COBALT PHARMACEUTICALS, INC. 12/14/2004

12 76-873 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG EON LABS, INC. 12/14/2004

13 75-827 GABAPENTIN TABLETS 600 MG AND 800 MG TEVA PHARMACEUTICALS USA 12/15/2004

14 76-607 QUINAPRIL TABLETS, USP 5 MG, 10 MG, 20 MG, AND 40 MG RANBAXY LABORATORIES LIMITED 12/15/2004

15 40-569 PROPOXYPHENE HYDROCHLORIDE CAPSULES, USP 65 MG MYLAN PHARMACEUTICALS, INC. 12/16/2004

16 76-831 FLAVOXATE HYDROCHLORIDE TABLETS 100 MG PADDOCK LABORATORIES, INC. 12/16/2004

17 76-872 HALOBETASOL PROPIONATE OINTMENT 0.05% AGIS INDUSTRIES (1983) LTD. 12/16/2004

18 76-903 HALOBETASOL PROPIONATE OINTMENT 0.05% ALTANA INC. 12/16/2004

19 76-922 FLUOXETINE CAPSULES, USP 10 MG, 20 MG, AND 40 MG PAR PHARMACEUTICAL, INC. 12/16/2004

20 76-994 HALOBETASOL PROPIONATE OINTMENT 0.05% TARO PHARMACEUTICALS USA, INC. 12/16/2004

21 77-001 HALOBETASOL PROPIONATE CREAM 0.05% ALTANA INC. 12/16/2004

22 77-123 HALOBETASOL PROPIONATE CREAM 0.05% AGIS INDUSTRIES (1983) LTD. 12/16/2004

23 65-175 NYSTATIN TOPICAL POWDER, USP 100,000 UNITS/GRAM X-GEN PHARMACEUTICALS, INC. 12/17/2004

24 76-574 ECONAZOLE NITRATE CREAM 1% HEALTHPOINT, LTD. 12/17/2004

25 76-739 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG AND 20 MG/12.5 MG RANBAXY LABORATORIES LIMITED 12/17/2004

26 75-317 TERAZOSIN HYDROCHLORIDE CAPSULES 1 MG (BASE), 2 MG (BASE), 5 MG (BASE), AND 10 MG (BASE) TRIGEN LABORATORIES, INC. 12/20/2004

27 40-581 PREDNISONE TABLETS, USP 2.5 MG VINTAGE PHARMACEUTICALS, INC. 12/21/2004

28 40-584 PREDNISONE TABLETS, USP 1 MG VINTAGE PHARMACEUTICALS, INC. 12/21/2004

29 76-679 MOMETASONE FUROATE CREAM, USP 0.1% TARO PHARMACEUTICALS U.S.A., INC. 12/21/2004

30 40-568 GLYCOPYRROLATE TABLETS, USP 1 MG AND 2 MG COREPHARMA LLC 12/22/2004

31 76-459 QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE) AMIDE PHARMACEUTICAL, INC. 12/22/2004

32 76-963 PILOCARPINE HYDROCHLORIDE TABLETS 5 MG ROXANE LABORATORIES, INC. 12/22/2004

33 76-694 QUINAPRIL HYDROCHLORIDE TABLETS 5 MG (BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE) MYLAN PHARMACEUTICALS, INC. 12/23/2004

34 76-855 HYDROMORPHONE HYDROCHLORIDE TABLETS, USP 8 MG MALLINCKRODT, INC. 12/23/2004

35 76-987 FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG AND 40 MG WATSON LABORATORIES, INC. 12/23/2004

36 65-139 CLINDAMYCIN PHOSPHATE VAGINAL CREAM, USP 2% (BASE) ALTANA INC. 12/27/2004

37 76-842 HYDROCORTISONE BUTYRATE OINTMENT, USP 0.1% TARO PHARMACEUTICAL INDUSTRIES LTD. 12/27/2004

38 40-600 HYDROXYZINE HYDROCHLORIDE TABLETS, USP 10 MG AMIDE PHARMACEUTICAL, INC. 12/28/2004

39 40-602 HYDROXYZINE HYDROCHLORIDE TABLETS, USP 25 MG AMIDE PHARMACEUTICAL, INC. 12/28/2004

40 40-604 HYDROXYZINE HYDROCHLORIDE TABLETS, USP 50 MG AMIDE PHARMACEUTICAL, INC. 12/28/2004

41 76-682 OXYBUTYNIN CHLORIDE SYRUP, USP 5 MG/5 ML VINTAGE PHARMACEUTICALS, LLC 12/28/2004

42 76-435 CICLOPIROX OLAMINE CREAM, USP 0.77% ALTANA INC. 12/29/2004