Drug Master Files for: phendimetrazine tartrate
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phendimetrazine tartrate Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
2093 | I | II | 4/6/1973 | DELMAR CHEMICALS INC | PHENDIMETRAZINE BITARTRATE (BULK POWDER) |
2097 | I | II | 4/25/1973 | GANES CHEMICALS INC PENNSVILLE DIV | PHENDIMETRAZINE BITARTRATE BULK |
2140 | A | II | 8/7/1973 | OLON SPA | PHENDIMETRAZINE TARTRATE |
2208 | I | 12/18/1973 | CYCLO CHEM DIV TRAVENOL LABS INC | PHENDIMETRAZINE TARTRATE | |
3135 | I | II | 12/15/1977 | KV PHARMACEUTICAL CO | PHENDIMETRAZINE TARTRATE SUSTAINED RELEASE CAPSULES 100 MG. |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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