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 ( |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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