Drug Master Files for: dapagliflozin

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dapagliflozin Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
27838	A	II	6/27/2015	ALP PHARM BEIJING CO LTD	DAPAGLIFLOZIN PROPANEDIOL
28086	A	II	3/25/2014	MSN LABORATORIES PRIVATE LTD	DAPAGLIFLOZIN PROPANEDIOL [ROUTE CODE - DQ]
30299	A	II	2/29/2016	MSN LABORATORIES PRIVATE LTD	DAPAGLIFLOZIN (AMORPHOUS) [ROUTE CODE DQa]
30555	A	II	5/12/2016	ZAKLADY FARMACEUTYCZNE POLPHARMA SA	DAPAGLIFLOZIN
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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