Drug Master Files for: fenfluramine hydrochloride
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fenfluramine hydrochloride Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10106 | I | II | 2/26/1993 | ORIL INDUSTRIE | DEXFENFLURAMINE HYDROCHLORIDE |
10871 | I | II | 4/14/1994 | LAKESIDE CHEMICAL | DEXFENFLURAMINE HYDROCHLORIDE |
10873 | I | II | 4/14/1994 | LABORATORIOS SERVIER SA | DEXFENFLURAMINE BASE |
11946 | I | II | 4/25/1996 | LABORATORI MAG SPA | FENFLURAMINE HYDROCHLORIDE |
11985 | I | II | 6/3/1996 | LABORATORI MAG SPA | DEXFENFLURAMINE HYDROCHLORIDE |
12056 | I | II | 7/22/1996 | PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA | FENFLURAMINE HYDROCHLORIDE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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