Drug Approval Package
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Gemcitabine Injection, 200 mg/5.3 mL, 1 g/26.3 mL, and 2 g/52.6 mL
Company: Hospira, Inc.
Application No.: 200795
Approval Date: 08/04/2011
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Cross Discipline Team Leader Review (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 Action Letter(s) (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: July 6, 2012
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