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Generated: October 17, 2018

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Drug Master Files for: Pierre Fabre

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Pierre Fabre Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11501 A II 5/11/1995 PIERRE FABRE MEDICAMENT MILNACIPRAN HYDROCHLORIDE (PROCESS I)
11527 I II 5/11/1995 PIERRE FABRE SANTE MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GAILLAC, FRANCE.
12899 I II 3/16/1998 PIERRE FABRE MEDICAMENT IDAZOXAN HYDROCHLORIDE
17199 I II 2/26/2004 PIERRE FABRE MEDICAMENT CICLOPIROX
DMF No. Status Type Submission Date Holder Subject

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Drug Master File Glossary

STATUS OF DMFS

  • A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
  • I = Inactive
  • N = Not an assigned number
  • P = DMF Pending Filing Review

TYPES OF DMFs

  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
  • Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
  • Type III Packaging Material
  • Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
  • Type V FDA Accepted Reference Information

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