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Last Updated: December 7, 2019

DrugPatentWatch Database Preview

Drug Master Files for: MITOMYCIN

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MITOMYCIN Drug Master Files

DMF No. Status Type Submission Date Holder Subject
13521 I II 9/1/1998 KYOWA HAKKO KOGYO CO LTD MITOMYCIN
13783 I II 9/1/1998 ZHEJIANG HISUN PHARMACEUTICAL CO LTD MITOMYCIN USP
13785 I II 9/1/1998 MICROBIOPHARM JAPAN CO LTD MITOMYCIN
13791 A II 9/1/1998 TEVA PHARMACEUTICAL INDUSTRIES LTD MITOMYCIN
18599 I II 7/14/1988 BIOLOGICAL THERAPY INSTITUTE MITOMYCIN-C CONJUGATED MURINE MONOCLONAL ANTIBODIES
25659 A II 12/30/2011 ZHEJIANG HISUN PHARMACEUTICAL CO LTD MITOMYCIN USP (ALTERNATIVE PROCESS)
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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

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