Drug Master Files for: vincristine sulfate
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vincristine sulfate Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
11285 | I | II | 1/3/1995 | ADITHYA ALKALOIDS LTD | VINCRISTINE SULFATE |
12626 | I | II | 8/21/1997 | HANA BIOSCIENCES INC | VINCRISTINE SULFATE LIPOSOME INJECTION |
18579 | I | II | 8/8/2005 | GUANGZHOU HUANYE PHARMACEUTICAL CO LTD | VINCRISTINE SULFATE USP (NON-STERILE BULK DRUG) |
3507 | I | II | 4/27/1979 | GEDEON RICHTER LTD | VINCRISTINE SULFATE |
4561 | A | II | 5/12/1982 | FINE CHEMICALS CORP PTY LTD | VINCRISTINE SULPHATE/VINBLASTINE SULPHATE |
4711 | I | II | 11/16/1982 | MEDIMPEX NORTHAMERICA INC | VINCRISTINE S04 FOR INJECT, USP 1mg & 5mg |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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