Generic Approvals - December 2005

ANDA Number Generic Drug Name Applicant Approval Date

1 77-053 RIBAVIRIN TABLETS, 200 MG TEVA PHARMACEUTICALS, INC. 12/5/2005

2 77-094 RIBAVIRIN TABLETS, 200 MG ZYDUS PHARMACEUTICALS USA, INC. 12/5/2005

3 77-456 RIBAVIRIN TABLETS, 200 MG, 400 MG, AND 600 MG THREE RIVERS PHARMACEUTICALS, LLC 12/5/2005

4 65-208 CEFPROZIL TABLETS USP, 250 MG AND 500 MG TEVA PHARMACEUTICALS USA 12/6/2005

5 76-446 OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 10 MG, 20 MG, AND 40 MG IMPAX LABORATORIES, INC. 12/6/2005

6 76-610 OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 10 MG, 20 MG, AND 40 MG TEVA PHARMACEUTICALS, USA 12/6/2005

7 77-272 CARBAMAZEPINE TABLETS USP, 100 MG, 200 MG, 300 MG, AND 400 MG CARACO PHARMACEUTICAL LABORATORIES, LTD. 12/7/2005

8 65-236 CEFPROZIL FOR ORAL SUSPENSION USP, 125 MG/5 ML AND 250 MG/5 ML TEVA PHARMACEUTICALS USA 12/8/2005

9 65-257 CEFPROZIL FOR ORAL SUSPENSION USP, 125 MG/5 ML AND 250 MG/5 ML SANDOZ INC. 12/8/2005

10 65-276 CEFPROZIL TABLETS USP, 250 MG AND 500 MG LUPIN LIMITED 12/8/2005

11 65-285 DOXYCYCLINE TABLETS, 50 MG AND 100 MG LANNETT HOLDINGS, INC. 12/8/2005

12 77-290 OXYCODONE HYDROCHLORIDE TABLETS USP, 5 MG, 10 MG, 15 MG, 20 MG, AND 30 MG KV PHARMACEUTICAL COMPANY 12/8/2005

13 77-376 MIRTAZAPINE ORALLY DISINTEGRATING TABLETS, 15 MG AND 30 MG AUROBINDO PHARMA LIMITED 12/8/2005

14 65-179 AZITHROMYCIN FOR INJECTION, 500 MG/VIAL AMERICAN PHARMACEUTICAL PARTNERS, INC. 12/13/2005

15 75-831 BISOPROLOL FUMARATE TABLETS, 5 MG AND 10 MG MYLAN PHARMACEUTICALS, INC. 12/14/2005

16 76-809 CLOZAPINE TABLETS USP, 50 MG, 100 MG, AND 200 MG GOLDLINE LABORATORIES, INC. 12/16/2005

17 77-184 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, 37.5 MG/325 MG CARACO PHARMACEUTICAL LABORATORIES LTD. 12/16/2005

18 65-261 CEFPROZIL FOR ORAL SUSPENSION USP, 125 MG/5 ML AND 250 MG/5 ML LUPIN LIMITED 12/19/2005

19 65-267 CEFPROZIL TABLETS USP, 250 MG AND 500 MG ORCHID HEALTHCARE 12/19/2005

20 77-426 RANITIDINE TABLETS USP, 150 MG AND 300 MG COBALT PHARMACEUTICALS, INC. 12/19/2005

21 40-664 METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION USP, 40 MG (BASE)/FLIPTOP VIAL HOSPIRA INC. 12/20/2005

22 40-665 METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION USP, 125 MG (BASE)/FLIPTOP VIAL HOSPIRA INC. 12/20/2005

23 77-241 BACLOFEN TABLETS USP, 20 MG LANNETT HOLDINGS, INC. 12/20/2005

24 65-281 DOXYCYCLINE HYCLATE DELAYED-RELEASE CAPSULES USP, 75 MG (BASE) AND 100 MG (BASE) SANDOZ INC. 12/21/2005

25 77-124 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 500 MG MUTUAL PHARMACEUTICAL COMPANY, INC. 12/21/2005

26 77-635 ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG MUTUAL PHARMACEUTICAL COMPANY, INC. 12/22/2005

27 77-636 ZONISAMIDE CAPSULES, 100 MG WOCKHARDT LIMITED 12/22/2005

28 77-637 ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG MYLAN PHARMACEUTICALS, INC. 12/22/2005

29 77-639 ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG BARR LABORATORIES, INC. 12/22/2005

30 77-641 ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG TEVA PHARMACEUTICALS USA 12/22/2005

31 77-642 ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG APOTEX INC. 12/22/2005

32 77-644 ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG SANDOZ INC. 12/22/2005

33 77-645 ZONISAMIDE CAPSULES, 100 MG DR. REDDY'S LABORATORIES LIMITED 12/22/2005

34 77-647 ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG ALPHAPHARM PTY LTD 12/22/2005

35 77-648 ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG ROXANE LABORATORIES, INC. 12/22/2005

36 77-370 GLIMEPIRIDE TABLETS, 1 MG, 2 MG, 4 MG, AND 8 MG PAR PHARMACEUTICAL INC. 12/23/2005

37 76-310 CABERGOLINE TABLETS, 0.5 MG PAR PHARMACEUTICAL, INC. 12/29/2005

38 76-520 FENOFIBRATE TABLETS, 107 MG PAR PHARMACEUTICAL, INC. 12/29/2005

39 40-608 OXYCODONE AND ACETAMINOPHEN TABLETS USP, 2.5 MG/300 MG, 5 MG/300 MG, 7.5 MG/300 MG, AND 10 MG/300 MG MIKART INC. 12/30/2005

40 65-284 CEFPROZIL FOR ORAL SUSPENSION USP, 125 MG/5 ML AND 250 MG/5 ML ORCHID HEALTHCARE 12/30/2005