Drug Approval Package
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Avapro
(irbesartan/hydrochlorothiazide) Tablets
Company: Bristol-Myers Squibb
Application No.: 20758S003
Approval Date: 8/31/1998
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Approval Letter(s) & Final Printed Labeling (PDF) (2.9 MB)
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Medical Review(s), Chemistry Review(s), Clinical Pharmacology Biopharmaceutics Review(s), & Administrative Document(s)/Correspondence (PDF) (2.4 MB)
Date created: September 10, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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