[Skip navigation] FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Drug Evaluation and Research
 HHS Logo links to Department of Health and Human Services website

FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER

horizonal rule

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 

Back to Top      Back to Approvals

Date created: August 2, 2005

horizonal rule

CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page

FDA/Center for Drug Evaluation and Research