Drug Master Files for: isosulfan blue

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isosulfan blue Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
20891	I	II	9/27/2007	SAFC PHARMA	ISOSULFAN BLUE
21883	A	II	8/13/2008	APICORE US LLC	ISOSULFAN BLUE
27795	A	II	12/21/2013	AUROBINDO PHARMA LTD	ISOSULFAN BLUE
29829	A	II	9/29/2015	BIOPHORE INDIA PHARMACEUTICALS PVT LTD	ISOSULFAN BLUE
31226	A	II	12/6/2016	DISHMAN CARBOGEN AMCIS LTD	ISOSULFAN BLUE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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