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Generated: May 26, 2019

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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

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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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

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