Drug Master Files for: CHLORPROPAMIDE
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CHLORPROPAMIDE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10384 | I | II | 7/30/1993 | PHARMACEUTICAL WORKS POLPHARMA SA | CHLORPROPAMIDE |
25127 | A | II | 5/11/2011 | KOTHARI PHYTOCHEMICALS INTERNATIONAL | CHLORPROPAMIDE USP |
2885 | I | II | 3/17/1977 | PLIVA PHARMACEUTICAL CHEMICAL FOOD & COSMETIC INDUSTRY | CHLORPROPAMIDE |
304 | I | II | 9/18/1958 | UPJOHN CO | CHLORPROPAMIDE TABLETS-PHARMACOLOGY, CLIN RPTS,G'S PROCEEDS. & CNTRL |
3514 | A | II | 3/2/1979 | DIPHARMA FRANCIS SRL | CHLORPROPAMIDE |
5483 | I | II | 7/20/1984 | HOECHST CELANESE CORP | CHLORPROPAMIDE USP |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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