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Food and Drug Administration

Cardiovascular and Renal Drugs Advisory Committee

April 18, 2007

 Briefing Information

NDA 20-758/S-037

AVALIDE (irbesartan/hydrochlorothiazide)

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

BRISTOL-MYERS SQUIBB (pdf)

FDA

Disclaimer

Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552). These redacted portions will appear as white space on the screen or on the printed page.

 Briefing Document (pdf)

Errata Sheet (pdf)

Page last updated April 13, 2007 kkhorizonal rule
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