Drug Approval Package

Prelay (Troglitazone) Tablets
Company:  Sankyo U.S.A. Corporation
Application No.:  020719/S012
Approval Date: 10/1/1999

• Approval Letter(s) (PDF) (733 KB)

• Final Printed Labeling (PDF) (2.6 MB)

• Medical Review(s)
  Part 1 (PDF) (2 MB)
  Part 2 (PDF) (2 MB)

• Administrative Document(s)/Correspondence
  Part 1 (PDF) (1.4 MB)
  Part 2 (PDF) (2.2 MB

 

Date created: March 30, 2001

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