Drug Master Files for: FINGOLIMOD HYDROCHLORIDE

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FINGOLIMOD HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
26401	A	II	11/5/2012	DR REDDYS LABORATORIES LTD	FINGOLIMOD HYDROCHLORIDE
26807	A	II	2/20/2013	GLENMARK PHARMACEUTICALS LTD	FINGOLIMOD HYDROCHLORIDE
27730	A	II	12/17/2013	MYLAN LABORATORIES LTD	FINGOLIMOD HYDROCHLORIDE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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