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Mifeprex (Mifepristone) Tablets

Mifeprex

Company: Danco Laboratories, LLC
Application No.: 20687
Approval Date: 03/29/2016

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

Approval Letter(s) (PDF)
Printed Labeling (PDF)
REMS (PDF)
Summary Review (PDF)
Cross Discipline Team Leader Review (PDF)
Medical Review(s) (PDF)
Chemistry Review(s) (PDF)
Pharmacology Review(s) (PDF)
Statistical Review(s) (PDF)
Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
Risk Assessment and Risk Mitigation Review(s) (PDF)
Other Review(s) (PDF)
Administrative Document(s) & Correspondence (PDF)

Date created: December 15, 2016

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