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 - September  2008

  Generic Drug Name Generic Manufacturer Brand Name Approval Date
1 GALANTAMINE HYDROBROMIDE EXTENDED-RELEASE CAPSULES 8 MG 16 MG 24 MG BARR LABORATORIES, INC. RAZADYNE ER 9/15/2008 
2 TECHNETIUM Tc 99m SESTAMIBI INJECTION (KIT FOR PREPARATION) MALLINCKRODT INC. CARDIOLITE INJECTION 9/22/2008 
3 KETAMINE HYDROCHLORIDE INJECTION USP, 10 MG (BASE)/ML (NEW STRENGTH); PACKAGED IN 200 MG (BASE)/20 ML MULTIPLE-DOSE VIALS BIONICHE PHARMA USA, LLC KETALAR INJECTION 9/30/2008 

Back to Top      Back to Approvals

Date created: November 5, 2008

horizonal rule