Drug Master Files for: mitomycin

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mitomycin Drug Master Files

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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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