Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 | Avalide (irbesartan/hydrochlorothiazide) Tablets, Sanofi-Synthelabo, Formulation Revision | Avapro (irbesartan) Tablets, Sanofi-Aventis, Labeling Revision | Avalide (irbesartan/hydrochlorothiazide) Tablets, Sanofi-Aventis, Labeling Revision | Avapro (irbesartan) Tablets, Bristol-Myers Squibb, Labeling Revision | Avapro (irbesartan) Tablets, Sanofi-Aventis, Labeling Revision | Avalide (irbesartan-hydrochlorothiazide) Tablets, Sanofi-Aventis, Labeling Revision | Avapro (irbesartan) Tablets, Sanofi-Aventis, Labeling Revision | Irbesartan Tabelts, Teva Pharma, Tentative Approval | Irbesartan Tablets, Sandoz Inc., Tentative Approval | Irbesartan and Hydrochlorothiazide Tablets, Sandoz Inc., Tentative Approval | Avalide (irbesartan/hydrochlorothiazide) Tablets, Sanofi-Aventis, New or Modified Indication | Irbesartan and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals, Inc., Tentative Approval ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com