Drug Master Files for: cytarabine

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cytarabine Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
1534	I	II	6/1/1970	PHARMACIA AND UPJOHN	CYTARABINE
15959	A	II	4/28/2002	ZHEJIANG HISUN PHARMACEUTICAL CO LTD	CYTARABINE USP
16896	A	II	10/6/2003	PFANSTIEHL INC	CYTARABINE USP
18071	I	II	1/21/2005	AXITEC CO LTD	CYTARABINE, USP
23469	I	II	1/12/2010	CHANGZHOU AHK TECH INC	CYTARABINE USP NON-STERILE BULK DRUG
25267	A	II	9/7/2011	EUTICALS SPA	CYTARABINE
26281	A	II	5/24/2012	MAC CHEM PRODUCTS INDIA PVT LTD	CYTARABINE USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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