Drug Master Files for: efinaconazole

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efinaconazole Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
27081	A	II	5/24/2013	KAKEN PHARMACEUTICAL CO LTD	EFINACONAZOLE
30420	A	II	3/30/2016	MAITHRI DRUGS PRIVATE LTD	EFINACONAZOLE [ROUTE CODE 'EC']
30538	A	II	5/31/2016	WAVELENGTH ENTERPRISES LTD	EFINACONAZOLE
30892	A	II	9/30/2016	GLENMARK PHARMACEUTICALS LTD	EFINACONAZOLE
31366	A	II	1/19/2017	VIRUPAKSHA ORGANICS LTD	EFINACONAZOLE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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