Drug Master Files for: flurazepam hydrochloride
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flurazepam hydrochloride Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
3501 | A | II | 2/28/1979 | CAMBREX PROFARMACO MILANO SRL | FLURAZEPAM HYDROCHLORIDE |
5282 | A | II | 2/27/1984 | FIS FABBRICA ITALIANA SINTETICI SPA | FLURAZEPAM HCl |
6508 | I | V | 7/17/1986 | LABORATORY ANALYTICAL BIOLOGY INC | VALIDATION REPORT ON FLURAZEPAM AND IT'S MAJOR METABOLITES |
6808 | I | II | 2/4/1987 | SANOFI CHIMIE | FLURAZEPAM 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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