Drug Master Files for: DECITABINE

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DECITABINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12851	I	II	2/5/1998	FERRO PFANSTIEHL INC	DECITABINE
23387	A	II	12/18/2009	SCINOPHARM TAIWAN LTD	DECITABINE
23596	A	II	3/3/2010	DR REDDYS LABORATORIES LTD	DECITABINE
25317	A	II	9/21/2011	INTAS PHARMACEUTICALS LTD	DECITABINE
25532	A	II	12/16/2011	FRESENIUS KABI ONCOLOGY LTD	DECITABINE
25988	A	II	4/23/2012	CQ INTERNATIONAL CO INC	DECITABINE
26256	A	II	2/21/2013	SUN PHARMACEUTICAL INDUSTRIES LTD	DECITABINE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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