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 |
17357 | A | II | 4/22/2004 | PIERRE FABRE MEDICAMENT | VINFLUNINE DITARTRATE |
21955 | I | II | 9/5/2008 | PIERRE FABRE MEDICAMENT PRODUCTION AQUITAINE PHARM INTERNATIONAL | VINFLUNINE INJECTION |
22351 | A | II | 12/22/2008 | PIERRE FABRE MEDICAMENT | LEVOMILNACIPRAN |
>DMF No. | >Status | >Type | >Submission Date | >Holder | >Subject |
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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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