Drug Master Files for: DISULFIRAM
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DISULFIRAM Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
15041 | A | II | 9/15/2000 | CORDEN PHARMA BERGAMO SPA | DISULFIRAM |
17406 | I | II | 5/28/2004 | POLYCARBON INDUSTRIES INC | DISULFIRAM USP |
20126 | A | II | 11/16/2006 | PCI SYNTHESIS | DISULFIRAM USP |
23288 | A | II | 11/20/2009 | APICORE US LLC | DISULFIRAM USP |
4986 | I | II | 6/17/1983 | SIEGFRIED AG | DISULFIRAM MANUF & SOLD UNDER SIEGFRIED LABEL |
5754 | I | II | 3/20/1985 | CILAG CHEMIE AG | DISULFIRAM |
6117 | I | II | 12/10/1985 | ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV | DISULFIRAM |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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