Drug Master Files for: MIRABEGRON

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MIRABEGRON Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
28071	A	II	3/20/2014	MSN LABORATORIES PRIVATE LTD	MIRABEGRON [ROUTE CODE MG]
28392	A	II	6/30/2014	DR REDDYS LABORATORIES LTD	MIRABEGRON [PRODUCT CODE: AEB]
28420	A	II	6/25/2014	OPTIMUS DRUGS PRIVATE LTD	(1R)-2-[(2-(4-NITROPHENYL) ETHYL] AMINO] -1- PHENYL ETHANOL. HCL (MIRABEGRON INTERMEDIATE)
29064	A	II	2/27/2015	DR REDDYS LABORATORIES LTD	MIRABEGRON [FORM - AMORPHOUS]
29734	A	II	9/28/2015	MICRO LABS LTD	MIRABEGRON
29773	A	II	9/25/2015	MEGAFINE PHARMA P LTD	MIRABEGRON DRUG SUBSTANCE
29889	A	II	10/6/2015	OPTIMUS DRUGS PRIVATE LTD	(R) -ALPHA-[[[2-(4-NITRO-PHENYL)-ETHYL]AMINO]METHYL]BENZENE METHANOL(MIRABEGRON INTERMEDIATE)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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