Drug Approval Package

Vicoprofen/Hydrocodone Bitartrate/Ibuprofen
Company: Knoll
Application No.:  20716
Approval Date: 9/23/1997

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• Approval Letter (149 KB)
• Medical Review(s)
• Part 1 (3 MB)
• Part 2 (2.8 MB)
• Chemistry Review(s), EA(Fonsi), Pharmacology Review(s), & Statistical Review(s) (4 MB)
• Clinical Pharmacology Biopharmaceutics Review(s) (2.4 MB)
  Administrative Documents (538 KB)

Date created: September 30, 1997

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