Drug Master Files for: EPLERENONE

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EPLERENONE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
19715	A	II	9/8/2006	INDUSTRIALE CHIMICA SRL	EPLERENONE
19796	I	II	9/25/2006	APOTEX PHARMACHEM INC	EPLERENONE MEK HEMISOLVATE (1:0.5)
23466	A	II	1/20/2010	MSN LABORATORIES PRIVATE LTD	EPLERENONE [ROUTE CODE: PL]
27672	A	II	12/25/2013	AURISCO PHARMACEUTICAL CO LTD	EPLERENONE
32998	A	II	11/30/2018	INDUSTRIALE CHIMICA SRL	EPLERENONE PH. EUR.
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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