Drug Approval Package

ZUPLENZ (ondansetron) oral soluble film, 4 mg and 8 mg
Company: Par Pharmaceutical, Inc.
Application No.: 022524
Approval Date: 07/02/2010

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• Approval Letter(s) (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Cross Discipline Team Leader Review (PDF)
• Printed Labeling (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Action Letter(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: May 13, 2011

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