Drug Approval Package

Moviprep (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) for oral solution
Company: Salix Pharmaceuticals
NDA: 21881
Approval Date: 08/02/2006

• Approval Letter(s) (PDF)
• Approvable Letter(s) (PDF)
• Printed Labeling (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Environmental Assessment (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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