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 - December 2008

  Generic Drug Name Generic Manufacturer Brand Name Approval Date
1 CLOBETASOL PROPIONATE LOTION, 0.05%        ACTAVIS MID ATLANTIC LLC CLOBEX TOPICAL LOTION 12/4/2008 
2 ACETAZOLAMIDE EXTENDED RELEASE CAPSULE 500 MG        ZYDUS PHARMACEUTICALS USA INC. DIAMOX CAPSULE, 500 MG 12/10/2008 
3 GEMCITABINE FOR INJECTION USP, 200 MG/SINGLE-USE VIAL        TEVA PARENTERAL MEDICINES, INC. GEMZAR FOR INJECTION 12/18/2008 
4 GEMCITABINE FOR INJECTION USP, 1 GRAM/SINGLE-USE VIAL        TEVA PARENTERAL MEDICINES, INC. GEMZAR FOR INJECTION 12/18/2008 
5 IBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLETS (OTC), 200 MG/38 MG        PERRIGO R&D COMPANY ADVIL PM TABLETS 200 MG/38 MG 12/22/2008 
6 LETROZOLE TALBETS USP, 2.5 MG        MYLAN PHARMACEUTICALS, INC. FEMARA TABLETS 12/24/2008 
7 STAVUDINE CAPSULES USP, 15 MG, 20 MG, 30 MG AND 40 MG     MATRIX LABORATORIES LIMITED ZERIT CAPSULES 12/29/2008 
8 STAVUDINE CAPSULES USP, 15 MG, 20 MG, 30 MG AND 40 MG     AUROBINDO PHARMA LIMITED ZERIT CAPSULES 12/29/2008 
9 STAVUDINE FOR ORAL SOLUTION USP, 1 MG/ML; (200 ML UPON RECONSTITUTION)       AUROBINDO PHARMA USA, INC. ZERIT FOR ORAL SOLUTION 12/29/2008 
10 STAVUDINE CAPSULES USP, 15 MG, 20 MG, 30 MG AND 40 MG     HETERO DRUGS LIMITED ZERIT CAPSULES 12/29/2008 

Back to Top      Back to Approvals

Date created: January 13, 2008

horizonal rule