Drug Master Files for: dacarbazine
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dacarbazine Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12862 | A | II | 2/13/1998 | HERAEUS DEUTSCHLAND GMBH AND CO KG | DACARBAZINE, USP |
| 16326 | I | II | 12/19/2002 | PLIVA LACHEMA AS | DACARBAZINE |
| 16411 | I | II | 1/31/2003 | GMT FINE CHEMCALS SA | DACARBAZINE USP |
| 25624 | A | II | 12/27/2011 | MAC CHEM PRODUCTS INDIA PVT LTD | DACARBAZINE USP |
| 30107 | A | II | 1/18/2016 | APICORE US LLC | DACARBAZINE USP |
| 3457 | I | II | 2/27/1979 | KYOWA HAKKO KOGYO CO LTD | DACARBAZINE ( |
| 4756 | I | II | 12/10/1982 | SOCIETE FRANCAISE D'ORGANO | DACARBAZINE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
