Drug Approval Package

Omnitrope (Somatropia [rDNA origin]) Injection
Company: Sandoz Inc.
Application No.:  021426
Approval Date: 05/30/2006

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Microbiology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created:  June 11, 2007

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