Drug Approval Package

Acutect (Kit For The Preparation Of Tecnetium Tc99m Apcitide) Injection
Company:  Diatide, Inc.
Application No.:  020-887
Approval Date: 9/14/1998

• Approval Letter, Approvable Letter, & Final Printed Labeling (PDF) (837 KB)

• Medical Review(s) (PDF) (3 MB)

• Chemistry Review(s) (PDF) (476 KB)

• Pharmacology Review(s)
  Part 1 (PDF) (1.9 MB)
  Part 2 (PDF) (1.6 MB)

• Statistical Review(s) & Microbiology Review(s) (PDF) (1.6 MB)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (2.2 MB)

• Administrative Document(s)/Correspondence (PDF) (2.6 MB)

Date created: March 30, 2001; last update: July 5, 2005

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