Drug Master Files for: LURASIDONE HYDROCHLORIDE

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LURASIDONE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
26700	A	II	3/22/2013	DR REDDYS LABORATORIES LTD	LURASIDONE HYDROCHLORIDE
27452	A	II	9/20/2013	GLENMARK PHARMACEUTICALS LTD	LURASIDONE HYDROCHLORIDE
27570	A	II	9/30/2013	MSN PHARMACHEM PRIVATE LTD	LURASIDONE HYDROCHLORIDE [ROUTE CODE - LN]
27584	A	II	12/5/2013	ALP PHARM BEIJING CO LTD	LURASIDONE HYDROCHLORIDE
27898	A	II	4/30/2014	AMSA SPA	LURASIDONE HYDROCHLORIDE
27963	A	II	4/11/2014	LUPIN LTD	LURASIDONE HYDROCHLORIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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