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U.S. Department of Health and Human Services

Drugs

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Approvals - July 2005

 Approvals - July 2005

  ANDA Number Generic Drug Name Applicant Approval Date
1 40-594 MERCAPTOPURINE TABLETS USP, 50 MG   MYLAN PHARMACEUTICALS, INC. 7/1/2005 
2 76-470 DESMOPRESSIN ACETATE TABLETS, 0.1 MG AND 0.2 MG   BARR LABORATORIES, INC. 7/1/2005 
3 40-648 ISONIAZID INJECTION USP, 100 MG/ML; PACKAGED IN 10 ML MULTIPLE-DOSE VIALS   SABEX 2002 INC. 7/5/2005 
4 40-498 DIPHENHYDRAMINE HYDROCHLORIDE INJECTION USP, 50 MG/ML; PACKAGED IN 10 ML MULTIPLE-DOSE VIALS   BIONICHE PHARMA 7/12/2005 
5 40-619 METHIMAZOLE TABLETS USP, 15 MG   CEDAR PHARMACEUTICALS LLC 7/12/2005 
6 76-973 ALCLOMETASONE DIPROPIONATE CREAM USP, 0.05%   ALTANA INC. 7/12/2005 
7 77-142 METHADONE HYDROCHLORIDE TABLETS USP, (DISKETS, DISPERSIBLE T 40 MG   MALLINCKRODT INC. 7/12/2005 
8 65-228 AMOXICILLIN TABLETS USP, 500 MG AND 875 MG   SANDOZ INC. 7/13/2005 
9 76-169 FEXOFENADINE HYDROCHLORIDE CAPSULES 60 MG   BARR LABORATORIES, INC. 7/13/2005 
10 77-005 HYDROCHLOROTHIAZIDE CAPSULES 12.5 MG   IVAX PHARMACEUTICALS, INC. 7/13/2005 
11 77-074 LORAZEPAM INJECTION USP (PRESERVATIVE-FREE), 2 MG/ML AND 4 MG/ML; PACKAGED IN 1 ML SINGLE-DOSE VIALS   BEDFORD LABORATORIES 7/13/2005 
12 77-076 LORAZEPAM INJECTION USP, 2 MG/ML AND 4 MG/ML; PACKAGED IN 10 ML MULTIPLE-DOSE VIALS   BEDFORD LABORATORIES 7/13/2005 
13 76-834 BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP, 150 MG (RLD=ZYBAN/GSK)   SANDOZ INC. 7/14/2005 
14 76-845 BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP, 100 MG AND 150 MG   SANDOZ INC. 7/14/2005 
15 40-582 FOLIC ACID TABLETS USP, 1 MG   MUTUAL PHARMACEUTICAL COMPANY, INC. 7/18/2005 
16 76-884 ALCLOMETASONE DIPROPIONATE OINTMENT USP, 0.05%   ALTANA INC. 7/18/2005 
17 77-114 IBUPROFEN TABLETS USP, 400 MG, 600 MG, AND 800 MG   PERRIGO R&D COMPANY 7/18/2005 
18 77-072 IPRATROPIUM BROMIDE INHALATION SOLUTION 0.02%; PACKAGED IN 0.5 MG/2.5 ML UNIT-DOSE VIALS   RxELITE 7/19/2005 
19 77-151 MILRINONE LACTATE IN 5% DEXTROSE INJECTION 20 MG (BASE)/100 ML; PACKAGED IN 20 MG (BASE)/100 ML AND 40 MG (BASE)/200 ML FLEXIBLE PLASTIC CONTAINERS   APOTEX CORP. 7/20/2005 
20 40-625 FOLIC ACID TABLETS USP, 1 MG   PHARMAX GROUP, INC. 7/21/2005 
21 76-705 RANITIDINE TABLETS USP, 150 MG AND 300 MG   DR. REDDY'S LABORATORIES LIMITED 7/27/2005 
22 77-352 FAMOTIDINE TABLETS USP, 20 MG AND 40 MG   PERRIGO R&D COMPANY 7/27/2005 
23 40-601 BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLETS USP, 50 MG/325 MG/40 MG   MUTUAL PHARMACEUTICAL COMPANY, INC. 7/29/2005 
24 65-166 CEFUROXIME AXETIL TABLETS USP, 125 MG (BASE), 250 MG (BASE), AND 500 MG (BASE)   WOCKHARDT LIMITED 7/29/2005 
25 65-221 RIFAMPIN AND ISONIAZID CAPSULES USP, 300 MG/150 MG   WEST-WARD PHARMACEUTICAL CORP. 7/29/2005 
26 76-915 DESOGESTREL AND ETHINYL ESTRADIOL TABLETS 0.15 MG/0.03 MG; PACKAGED IN 28-DAY CYCLES   WATSON LABORATORIES, INC. 7/29/2005 
27 77-105 VALPROIC ACID SYRUP USP, 250 MG/5 ML   APOTEX INC. 7/29/2005 
28 77-121 BACLOFEN TABLETS USP, 20 MG   ALPHAPHARM PTY. LTD. 7/29/2005 
29 77-181 BACLOFEN TABLETS USP, 10 MG   ALPHAPHARM PTY. LTD. 7/29/2005 
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