Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

FDA Approval Activities for this Drug… Avalide (irbesartan/hydrochlorothiazide) Tablets,72/12.5, 150/12.5, & 300/12.5 mg, Bristol-Myers Squibb NDA 20-758/S16 Avapro (irbesartan) Tablets, 75, 150, & 300 mg, Sanofi-Synthelabo, NDA 20-757/S22 7/19/02 7/24/02 Avapro (irbesartan) Tablets, 75, 150, & 300 mg, Sanofi-Synthelabo, NDA 20-757/S21 9/17/02 9/20/02 9/17/02 11/22/02 Avapro (irbesartan) Tablets, 75, 150, & 300 mg, Bristol-Myers Squibb NDA 20-757/S16 5/10/00 6/6/01 Avapro (irbesartan) Tablets, 75, 150, & 300 mg, Bristol-Myers Squibb NDA 20-757/S15 5/9/00 6/6/01 Avapro (irbesartan) Tablets, Bristol-Myers Squibb NDA 20-757/S14 5/26/01 12/4/01 Avapro HCT Tablets, 75/12.5 & 150/12.5 Bristol-Myers Squibb NDA 20-758/S-003 8/31/98 3/10/00   For the latest approval information, locate this drug using this index.