Drug Approval Package

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Drug Approval Package

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OsmoPrep
(sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP)
Company: Salix Pharmaceuticals, Inc.
NDA: 21892
Approval Date: 03/16/2006

Approval Letter(s) (PDF)
Printed Labeling (PDF)
Medical Review(s) (PDF)
Chemistry Review(s) (PDF)
Pharmacology Review(s) (PDF)
Statistical Review(s) (PDF)
Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Proprietary Name Review(s) (PDF)
Administrative Document(s) and Correspondence (PDF)

Date created: September 5, 2008

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