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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 | Irbesartan Tablets, Cipla Ltd., Tentative Approval | Avalide (irbesartan and hydrochlorothiazide) Tablets, Bristol-Myers Squibb Company, Labeling Revision | Irbesartan Tablets, Alembic Limited, Tentative Approval | Irbesartan Tablets, Zydus Pharmaceuticals USA Inc., Tentative Approval | Irbesartan and Hydrochlorothiazide Tablets, Zydus Pharmaceuticals USA Inc., Tentative Approval | Irbesartan and Hydrochlorothiazide Tablets, Roxane Laboratories, Inc., Tentative Approval | Avalide (hydrochlorothiazide and irbesartan) Tablets, Sanofi-Aventis, Labeling Revision | Avapro (irbesartan) Tablets, Sanofi-Aventis, Labeling Revision | Irbesartan Tablets, Mylan Pharmaceuticals Inc., Tentative Approval | Irbesartan Tablets, Lupin Limited, Tentative Approval | Irbesartan Tablets, MacLeods Pharmaceuticals Ltd., Tentative Approval | Irbesartan and Hydrochlorothiazide Tablets, MacLeods Pharmaceuticals Ltd., Tentative Approval | Avapro (irbesartan) Tablets, Sanofi-Aventis, Labeling Revision
  
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