Drug Master Files for: carmustine
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carmustine Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10290 | A | II | 6/14/1993 | JOHNSON MATTHEY PHARMACEUTICAL MATERIALS | CARMUSTINE |
13169 | A | II | 9/1/1998 | AMPAC FINE CHEMICALS LLC | CARMUSTINE (BCNU) |
2038 | I | II | 1/10/1973 | BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO | CARMUSTINE (BCNU) BULK & CARMUSTINE (BCNU) FOR INJ |
22637 | A | II | 3/20/2009 | CHEMPACIFIC CORP | CARMUSTINE DRUG SUBSTANCE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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