Drug Approval Package

Priftin/Rifapentine
Company:  Hoechst Marion Roussel, Inc.
Application No.:  21024
Approval Date: 6/221998

• Approval Letter and Medical Review (PDF)

• Medical Review: Part 2 (PDF)

• Chemistry Review (PDF)

• Microbiology Review (PDF)

• Statistical Review (PDF)

Date created: March 30, 2001; last update: July 1, 2005

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.