Drug Master Files for: BELINOSTAT

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BELINOSTAT Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
26926	A	II	9/27/2013	SPECTRUM PHARMACEUTICALS INC	BELINOSTAT DRUG SUBSTANCE
31134	A	II	12/30/2016	TIANJIN WEIJIE PHARMACEUTICAL CO LTD	BELINOSTAT
32260	A	II	1/5/2018	FRESENIUS KABI ONCOLOGY LTD	BELINOSTAT
32405	A	II	4/11/2018	BIOPHORE INDIA PHARMACEUTICALS PVT LTD	BELINOSTAT
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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