Drug Master Files for: CLOFARABINE

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CLOFARABINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
25633	A	II	2/15/2012	APICORE US LLC	CLOFARABINE
26635	A	II	9/27/2012	OLON SPA	CLOFARABINE
27566	A	II	12/31/2014	SCINOPHARM TAIWAN LTD	CLOFARABINE
27797	A	II	12/30/2013	EMCURE PHARMACEUTICALS LTD	CLOFARABINE
27862	A	II	1/24/2014	MSN LABORATORIES PRIVATE LTD	CLOFARABINE [ROUTE CODE CF]
27901	A	II	2/5/2014	BIOPHORE INDIA PHARMACEUTICALS PVT LTD	CLOFARABINE
29318	A	II	9/10/2015	SUN PHARMACEUTICAL INDUSTRIES LTD	CLOFARABINE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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