Drug Master Files for: PHENOBARBITAL SODIUM
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PHENOBARBITAL SODIUM Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
1003 | I | II | 10/19/1966 | NYSCO LABS INC | PHENOBARBITAL TIMED RELEASE PELLETS |
1049 | A | II | 3/21/1967 | SIEGFRIED USA LLC | PHENOBARBITAL SODIUM USP |
1171 | I | II | 4/17/1968 | GANES CHEMICALS INC PENNSVILLE DIV | G. PACKAGING AND ANALYSIS OF SODIUM PHENOBARBITAL |
1322 | I | 2/12/1969 | VICTOR M HERMELIN CO DIV K-V PHARMACAL CO | DILAC 30MG /PHENOBARBITAL 45MG SUSTAINED RELEASE CAPSULES | |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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