Drug Master Files for: azacitidine

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azacitidine Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
22360	A	II	12/31/2008	SCINOPHARM TAIWAN LTD	AZACITIDINE
22801	A	II	5/26/2009	APICORE US LLC	AZACITIDINE
23416	A	II	12/22/2009	CHEMWERTH INC	AZACITIDINE NON-STERILE BULK DRUG SUBSTANCE
23564	A	II	2/23/2010	DR REDDYS LABORATORIES LTD	AZACITIDINE
25265	I	II	9/7/2011	EUTICALS SPA	AZACITIDINE
26126	A	II	6/4/2012	TEVA PHARMACEUTICAL INDUSTRIES LTD	AZACITIDINE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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