Drug Approval Package

 Increlex (Mecasermin [rDNA origin]) Injection
Company:  Tercica, Inc.
Application No.:  021839
Approval Date: 8/30/2005

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)

• Microbiology Review(s) (PDF)

• Administrative Document(s) & Correspondence (PDF)  

Date created: October 12, 2005

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