[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

First-Time Generics - May 2004

  Generic Drug Name Generic Manufacturer Brand Name Approval Date
1 PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 MG/325 MG VINTAGE PHARMACEUTICALS, INC. DARVOCET-N 100 5/7/2004
2 OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% HI-TECH PHARMACAL CO., INC. OCUFLOX OPHTHALMIC SOLUTION 5/14/2004
3 FLUTICASONE PROPIONATE CREAM 0.05% ALTANA INC. CUTIVATE CREAM 5/14/2004
4 FLUTICASONE PROPIONATE CREAM 0.05% CLAY-PARK LABS, INC. CUTIVATE CREAM 5/14/2004
5 FLUTICASONE PROPIONATE OINTMENT 0.005% CLAY-PARK LABS, INC. CUTIVATE OINTMENT 5/14/2004
6 FLUTICASONE PROPIONATE CREAM 0.05% ATRIX LABORATORIES, INC, CUTIVATE CREAM 5/14/2004
7 FLUTICASONE PROPIONATE OINTMENT 0.005% ALTANA INC. CUTIVATE OINTMENT 5/14/2004
8 OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% BAUSCH & LOMB, INC. OCUFLOX OPHTHALMIC SOLUTION 5/14/2004
9 OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% ALCON INC. OCUFLOX OPHTHALMIC SOLUTION 5/14/2004
10 CLARITHROMYCIN TABLETS, USP 250 MG AND 500 MG ROXANE LABORATORIES, INC. BIAXIN FILMTAB 5/25/2004
11 BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS 150 MG (RLD = ZYBAN/GSK) IMPAX LABORATORIES, INC. ZYBAN SUSTAINED-RELEASE TABLETS 5/27/2004
12 ITRACONAZOLE CAPSULES 100 MG EON LABS, INC. SPORANOX CAPSULES 5/28/2004
13 METRONIDAZOLE TOPICAL CREAM 0.75% ALTANA INC. METROCREAM TOPICAL CREAM 5/28/2004

Back to Top     Back to Approvals

Date created: June 16, 2004

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