Drug Approval Package

Phenylephrine Hydrochloride Injection, 10 mg/mL
Company: West-Ward Pharmaceutical Corp.
Application No.: 203826
Approval Date: 12/20/2012

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• Approval Letter(s) (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Printed Labeling (PDF)
• Medical Review(s) (PDF)
• Microbiology Review (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Statistical Review (PDF)
• Other Action Letter(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: May 24, 2013

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