Drug Approval Package

 Hydase (Hyaluronidase) Injection
Company:  PrimaPharm, Inc.
Application No.:  021716
Approval Date: 10/25/2005

• Approval Letter(s) (PDF)

• Approvable Letter (PDF)

• Printed Labeling (PDF)

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)

• Pharmacology Review(s) (PDF)  

• Microbiology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) & Correspondence (PDF)  

Date created: December 282005

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