Drug Approval Package

Mifeprex (Mifepristone) Tablet
Company:  Population Council
Application No.:  20687
Approval Date: 9/28/2000

• Approval Letter, 9/28/2000 (PDF) (656 KB)

• Approvable Letter(s), 2/18/1996(PDF) (879 KB) and 2/18/2000(PDF) (656 KB)

• Approved Labeling Text. Optional Format: PDF.   9/28/00

• Medical Review(s), 9/28/00
  Part 1(PDF) (2.8 MB)
  Part 2(PDF) (3 MB)

• Chemistry Review(s), 9/28/00 (PDF) (1.3 MB)

• Environmental Assessment, 9/28/00 (PDF) (2.1 MB)

• Pharmacology Review(s), 9/28/00
  Part 1(PDF) (1.8 MB)
  Part 2(PDF) (1.9 MB)

• Statistical Review(s), 9/28/00 (PDF) (1.8 MB)

• Clinical Pharmacology Biopharmaceutics Review(s), 9/28/00
  Part 1(PDF) (2.8 MB)
  Part 2(PDF) (2.3 MB)
  Part 3(PDF) (2.6 MB)

Date created: June 18, 2001

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