Tentative Approvals - September 2003

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ANDA Number Generic Drug Name Applicant Tentative Approval Date
1 76-318 OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS 80 MG IMPAX LABORATORIES, INC. 9/4/2003

2 76-467 GLIPIZIDE EXTENDED-RELEASE TABLETS 10 MG WATSON LABORATORIES, INC. 9/8/2003

3 76-306 TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MG ROXANE LABORATORIES, INC. 9/8/2003

4 76-523 MEFLOQUINE HYDROCHLORIDE TABLETS 250 MG ROXANE LABORATORIES, INC. 9/12/2003

5 76-564 ADENOSINE INJECTION, USP 3 MG/ML PACKAGED IN 6 MG/2 ML AND 12 MG/4 ML SINGLE-DOSE VIALS SICOR PHARMACEUTICALS, INC. 9/23/2003

6 76-583 KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION 0.5% ALCON INC. 9/24/2003

7 76-089 CIPROFLOXACIN TABLETS, USP 100 MG, 250 MG, 500 MG, AND 750 MG IVAX PHARMACEUTICALS, INC. 9/25/2003

8 76-432 FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG GEDEON RICHTER LTD. 9/25/2003

9 76-285 SIMVASTATIN TABLETS, USP 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MG RANBAXY LABORATORIES, LIMITED 9/26/2003

10 76-343 TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MG IVAX PHARMACEUTICALS, INC. 9/26/2003

11 76-168 OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS 80 MG TEVA PHARMACEUTICALS USA 9/29/2003

12 75-716 PAROXETINE HYDROCHLORIDE TABLETS 10 MG, 20 MG, 30 MG, AND 40 MG ALPHAPHARM PTY., LTD. 9/29/2003

13 76-445 PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, 40 MG, AND 80 MG RANBAXY LABORATORIES LIMITED 9/30/2003

14 76-341 PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, AND 40 MG TORPHARM INC. 9/30/2003

15 76-342 BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS 5 MG/6.25 MG, 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG ANDRX PHARMACEUTICALS, INC. 9/30/2003

Date created: 10/9/2003