Drug Master Files for: COLCHICINE
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COLCHICINE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10088 | A | II | 2/10/1993 | INDENA SPA | COLCHICINE USP |
| 11771 | I | II | 12/12/1995 | SM ORGANICS PRIVATE LTD | COLCHICINE |
| 17003 | I | II | 12/1/2003 | ALCHEM INTERNATIONAL LTD | COLCHICINE USP |
| 18032 | I | II | 1/25/2005 | ALKALOIDS CORP | COLCHICINE USP |
| 20149 | A | II | 1/12/2007 | SANMAR SPECIALITY CHEMICALS LTD | COLCHICINE USP NON-STERILE BULK DRUG SUBSTANCE |
| 2113 | I | II | 6/13/1973 | LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO | #560 COLCHICINE |
| 22115 | A | II | 10/29/2008 | INDENA SPA | IDN 5404 (THIOCOLCHICINE DERIVATIVE) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
