Drug Approval Package

Docetaxel Injection Concentrate, 20 mg/mL, 80 mg/4 mL, 140 mg/7 mL
Company: Actavis, Inc.
Application No.: 203551
Approval Date: 04/12/2013

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• Approval Letter(s) (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Environmental Assessment (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)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: October 21, 2013

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