Other Publication
Approvals

All Approvals August 2010

This report lists both original approvals and supplemental approvals to NDAs, ANDAs, and BLAs* during the month of November. It includes tentative approvals and original appr0ovals.
Drug Name and
FDA Appl. #
Suppl. # Active Ingredients Company Approval Type Approval Date
LEVETIRACETAM (ANDA # 090484) 000 LEVETIRACETAM ORCHID HLTHCARE Approval 08/05/2010
LAMIVUDINE AND STAVUDINE (NDA # 022541) 000 LAMIVUDINE; STAVUDINE MACLEODS PHARMA Tentative Approval 08/05/2010
SUPREP (NDA # 022372) 000 SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE BRAINTREE Approval 08/05/2010
FAMOTIDINE (ANDA # 090837) 000 FAMOTIDINE WOCKHARDT Approval 08/04/2010
VENLAFAXINE HYDROCHLORIDE (ANDA # 090027) 000 VENLAFAXINE HYDROCHLORIDE VINTAGE Approval 08/04/2010
BRIMONIDINE TARTRATE; TIMOLOL MALEATE (ANDA # 091574) 000 BRIMONIDINE TARTRATE; TIMOLOL MALEATE ALCON Tentative Approval 08/03/2010
ERGOCALCIFEROL (ANDA # 090455) 000 ERGOCALCIFEROL STRIDES ARCOLAB LTD Approval 08/03/2010
CLOTRIMAZOLE (ANDA # 090219) 000 CLOTRIMAZOLE GLENMARK PHARMS Approval 08/03/2010
ALTAVERA (ANDA # 079102) 000 ETHINYL ESTRADIOL; LEVONORGESTREL SANDOZ Approval 08/03/2010
Web Counter: