Drug Master Files for: MAFENIDE ACETATE

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MAFENIDE ACETATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12419	A	II	3/17/1997	AMRI RENSSELAER INC	SULFAMYLON (MAFENIDE) ACETATE
24615	A	II	5/3/2011	APICORE US LLC	MAFENIDE ACETATE USP
24722	A	II	3/8/2011	ALCHYMARS ICM SM PRIVATE LTD	MAFENIDE ACETATE USP
32292	A	II	12/19/2017	MYLAN LABORATORIES LTD	MAFENIDE ACETATE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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