Tentative Approvals - October 2005

ANDA Number Generic Drug Name Applicant Tentative Approval Date

1 77-291 CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP, 5 MG AMIDE PHARMACEUTICAL, INC. 10/4/2005

2 76-950 GATIFLOXACIN TABLETS 200 MG AND 400 MG TEVA PHARMACEUTICALS USA 10/5/2005

3 76-714 PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, 40 MG, AND 80 MG DR. REDDY'S LABORATORIES, LIMITED 10/5/2005

4 77-456 RIBAVIRIN TABLETS 200 MG, 400 MG, AND 600 MG THREE RIVERS PHARMACEUTICALS, LLC 10/20/2005

5 77-300 ZOLPIDEM TARTRATE TABLETS 5 MG AND 10 MG PLIVA HRVATSKA D.O.O. 10/28/2005

6 77-158 OLANZAPINE TABLETS 2.5 MG, 5 MG, 7.5 MG, 10 MG, 15 MG, AND 20 MG SANDOZ INC. 10/31/2005