Drug Master Files for: PHYTONADIONE

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PHYTONADIONE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
26447	A	II	9/26/2012	BIOPHORE INDIA PHARMACEUTICALS PVT LTD	PHYTONADIONE
26654	A	II	11/19/2012	G AND A ASSOCS LLC	PHYTONADIONE USP, NON STERILE, BULK DRUG
27805	A	II	12/28/2013	BIOPHORE INDIA PHARMACEUTICALS PVT LTD	PHYTONADIONE ROUTE-B
29669	A	II	9/30/2015	MSN LABORATORIES PRIVATE LTD	PHYTONADIONE USP [ROUTE CODE HN]
30176	I	II	9/24/2016	ENALTEC LABS PRIVATE LTD	PHYTONADIONE USP
30775	A	II	9/17/2016	EMCURE PHARMACEUTICALS LTD	PHYTONADIONE USP
30910	A	II	9/20/2016	NAVINTA LLC	PHYTONADIONE USP (PROCESS A)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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