Drug Approval Package

Sucraid (sacrosidase) Oral Solution
Company:  Orphan Medical, Inc.
Application No.:  20-772
Approval Date: 4/9/1998

• Approval Letter (PDF)

• Approvable Letter (PDF)

• Chemistry Review (PDF)

• Clinical Pharmacology and Biopharmaceutics Review (PDF)

• Microbiology Review (PDF)

• Pharmacology Review (PDF)

• Statistical Review (PDF)

• Medical Review: Part 1 (PDF)

• Medical Review: Part 2 (PDF)

• Medical Review: Part 3 (PDF)

• Medical Review: Part 4 (PDF)

• Administrative and Correspondence Documents (PDF)

Date created: March 08, 2001; last update: July 5, 2005

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