Generic Approvals - July 2004

ANDA Number Generic Drug Name Applicant Approval Date

1 40-558 PROMETHAZINE HYDROCHLORIDE TABLETS, USP 12.5 MG, 25 MG, AND 50 MG ABLE LABORATORIES, INC. 7/1/2004

2 76-652 GLYCOLAX (POLYETHYLENE GLYCOL 3350 POWDER FOR ORAL SOLUTION) SCHWARZ PHARMA, INC. 7/2/2004

3 65-157 PIPERACILLIN FOR INJECTION, USP 40 G/VIAL (PHARMACY BULK PACKAGE) ISTITUTO BIOCHIMICO ITALIANO, S.P.A. 7/12/2004

4 65-203 NYSTATIN TOPICAL POWDER, USP 100,000 UNITS/GRAM TANON PHARMACEUTICALS LLC 7/15/2004

5 76-020 MIDAZOLAM HYDROCHLORIDE INJECTION 1 MG (BASE)/ML AND 5 MG (BASE)/ML INTERNATIONAL MEDICATION SYSTEMS, LIMITE 7/16/2004

6 76-853 TERBUTALINE SULFATE INJECTION, USP 1 MG/ML; PACKAGED IN 1 ML SINGLE-DOSE VIALS SICOR PHARMACEUTICALS, INC. 7/20/2004

7 75-772 KETOROLAC TROMETHAMINE INJECTION, USP 15 MG/ML, 30 MG/ML, AND 60 MG/2 ML; SINGLE-DOSE VIALS. BAXTER HEALTHCARE CORPORATION 7/21/2004

8 76-209 KETOROLAC TROMETHAMINE INJECTION, USP 15 MG/ML, 30 MG/ML, AND 60 MG/2 ML, PACKAGED IN SINGLE-DOSE VIALS AMPHASTAR PHARMACEUTICALS, INC. 7/21/2004

9 76-891 METOLAZONE TABLETS, USP 10 MG WATSON LABORATORIES, INC. 7/21/2004

10 40-559 HYDROXYZINE HYDROCHLORIDE TABLETS, USP 10 MG ABLE LABORATORIES, INC. 7/22/2004

11 40-562 HYDROXYZINE HYDROCHLORIDE TABLETS, USP 25 MG ABLE LABORATORIES, INC. 7/22/2004

12 40-563 HYDROXYZINE HYDROCHLORIDE TABLETS, USP 50 MG ABLE LABORATORIES, INC. 7/22/2004

13 65-138 NYSTATIN TOPICAL POWDER, USP 100,000 UNITS/GRAM KALI LABORATORIES, INC. 7/23/2004

14 76-883 SOTALOL HYDROCHLORIDE TABLETS, USP (AF) 80 MG, 120 MG, AND 160 MG TEVA PHARMACEUTICALS USA 7/26/2004

15 40-483 BETHANECHOL CHLORIDE TABLETS, USP 10 MG ABLE LABORATORIES, INC. 7/27/2004

16 40-485 BETHANECHOL CHLORIDE TABLETS, USP 25 MG ABLE LABORATORIES, INC. 7/27/2004

17 40-492 BETHANECHOL CHLORIDE TABLETS, USP 5 MG ABLE LABORATORIES, INC. 7/27/2004

18 40-509 BETHANECHOL CHLORIDE TABLETS, USP 50 MG ABLE LABORATORIES, INC. 7/27/2004

19 76-722 KETOROLAC TROMETHAMINE INJECTION, USP 15 MG/1 ML, 30 MG/1 ML AND 60 MG/2 ML; PACKAGED IN SINGLE-DOSE SYRINGES APOTEX CORP. 7/27/2004

20 76-493 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE LOTION 1%/0.05% (BASE) TARO PHARMACEUTICALS U.S.A., INC. 7/28/2004

21 76-553 MEDROXYPROGESTERONE ACETATE INJECTABLE SUSPENSION, USP 150 MG/1 ML SINGLE-DOSE VIALS SICOR PHARMACEUTICALS, INC. 7/28/2004

22 74-681 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG NOVOPHARM LIMITED 7/29/2004

23 76-042 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG GENPHARM INC. 7/29/2004

24 76-077 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG IVAX PHARMACEUTICALS, INC. 7/29/2004

25 76-086 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG SANDOZ INC. 7/29/2004

26 76-087 FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML SINGLE-DOSE VIALS. BEDFORD LABORATORIES 7/29/2004

27 76-145 FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML SINGLE-DOSE VIALS AMERICAN PHARMACEUTICAL PARTNERS, INC. 7/29/2004

28 76-213 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG ROXANE LABORATORIES, INC. 7/29/2004

29 76-246 FLUCONAZOLE FOR ORAL SUSPENSION 10 MG/ML (50 MG/5 ML) AND 40 MG/ML (200 MG/5 ML) ROXANE LABORATORIES, INC. 7/29/2004

30 76-303 FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML SINGLE-DOSE PLASTIC CONTAINERS. HOSPIRA, INC. 7/29/2004

31 76-304 FLUCONAZOLE INJECTION (IN 5% DEXTROSE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML SINGLE-DOSE PLASTIC CONTAINERS HOSPIRA, INC. 7/29/2004

32 76-332 FLUCONAZOLE FOR ORAL SUSPENSION 10 MG/ML (50 MG/5 ML) AND 40 MG/ML (200 MG/5 ML) RANBAXY LABORATORIES LIMITED 7/29/2004

33 76-351 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG MYLAN PHARMACEUTICALS, INC. 7/29/2004

34 76-386 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, 200 MG RANBAXY LABORATORIES LIMITED 7/29/2004

35 76-387 CLOTRIMAZOLE LOZENGES, USP 10 MG ROXANE LABORATORIES, INC. 7/29/2004

36 76-424 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG PLIVA INC. 7/29/2004

37 76-432 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG GEDEON RICHTER LTD. 7/29/2004

38 76-507 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG TARO PHARMACEUTICAL INDUSTRIES, LTD. 7/29/2004

39 76-568 NICOTINE POLACRILEX GUM, USP (MINT-FLAVORED) (OTC) 4 MG (BASE) WATSON LABORATORIES, INC. 7/29/2004

40 76-569 NICOTINE POLACRILEX GUM, USP (MINT FLAVORED) (OTC) 2 MG (BASE) WATSON LABORATORIES, INC. 7/29/2004

41 76-617 FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML SINGLE-DOSE PLASTIC CONTAINERS MAYNE PHARMA (USA) INC. 7/29/2004

42 76-653 FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML, AND 400 MG/200 ML SINGLE-DOSE VIALS SICOR PHARMACEUTICALS, INC. 7/29/2004

43 76-658 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG DR. REDDY'S LABORATORIES LIMITED 7/29/2004

44 76-665 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG APOTEX INC. 7/29/2004

45 76-730 ALCLOMETASONE DIPROPIONATE OINTMENT, USP 0.05% TARO PHARMACEUTICALS USA, INC. 7/29/2004

46 76-766 FLUCONAZOLE INJECTION (IN 0.9% SODIUM CHLORIDE INJECTION) 2 MG/ML; PACKAGED IN 200 MG/100 ML AND 400 MG/200 ML SINGLE-DOSE PLASTIC CONTAINERS BAXTER HEALTHCARE CORPORATION 7/29/2004

47 40-583 METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION, USP 40 MG (BASE)/VIAL AND 125 MG (BASE)/VIAL AMERICAN PHARMACEUTICAL PARTNERS, INC. 7/30/2004

48 65-024 GENTAMICIN OPHTHALMIC OINTMENT, USP 0.3% ALTANA INC. 7/30/2004

49 76-249 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS 500 MG IMPAX LABORATORIES, INC. 7/30/2004

50 76-907 ATENOLOL TABLETS, USP 25 MG, 50 MG, AND 100 MG ABLE LABORATORIES, INC. 7/30/2004