Drug Master Files for: EMPAGLIFLOZIN

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EMPAGLIFLOZIN Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
29796	A	II	9/23/2015	ALP PHARM BEIJING CO LTD	EMPAGLIFLOZIN
29801	A	II	10/23/2015	BEIJING HUIKANG BOYUAN CHEMICAL TECH CO LTD	EMPAGLIFLOZIN
31087	A	II	10/28/2016	MYLAN LABORATORIES LTD	EMPAGLIFLOZIN
31501	A	II	4/13/2017	LUPIN LTD	EMPAGLIFLOZIN
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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