Tentative Approvals - August 2004

ANDA Number Generic Drug Name Applicant Tentative Approval Date

1 77-011 ONDANSETRON INJECTION USP (PRESERVATIVE-FREE) 2 MG (BASE)/ML, PACKAGED IN 4 MG (BASE)/2 ML SINGLE-DOSE VIALS BEDFORD LABORATORIES 8/11/2004

2 76-967 ONDANSETRON INJECTION, USP 2 MG (BASE)/ML, PACKAGED IN 40 MG (BASE)/20 ML MULTIPLE-DOSE VIALS BEDFORD LABORATORIES 8/11/2004

3 76-671 SERTRALINE HYDROCHLORIDE TABLETS 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE) MYLAN PHARMACEUTICALS INC. 8/12/2004

4 76-677 CETIRIZINE HYDROCHLORIDE TABLETS 5 MG AND 10 MG MYLAN PHARMACEUTICALS, INC. 8/20/2004

5 76-606 GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG RANBAXY LABORATORIES LIMITED 8/25/2004

6 76-693 ONDANSETRON ORALLY DISINTEGRATING TABLETS 4 MG AND 8 MG BARR LABORATORIES, INC. 8/26/2004