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

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