Drug Master Files for: DABIGATRAN ETEXILATE MESYLATE

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DABIGATRAN ETEXILATE MESYLATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
27037	A	II	6/29/2013	MSN LABORATORIES PRIVATE LTD	DABIGATRAN ETEXILATE MESYLATE [ROUTE CODE - DE]
27620	A	II	10/1/2013	ZAKLADY FARMACEUTYCZNE POLPHARMA SA	DABIGATRAN ETEXILATE METHANESULFONATE
27781	A	II	12/31/2013	ALEMBIC PHARMACEUTICALS LTD	DABIGATRAN ETEXILATE MESYLATE
27892	A	II	3/25/2014	GLENMARK PHARMACEUTICALS LTD	DABIGATRAN ETEXILATE MESYLATE
27960	A	II	4/4/2014	DR REDDYS LABORATORIES LTD	DABIGATRAN ETEXILATE MESYLATE
28029	A	II	3/28/2014	APOTEX PHARMACHEM INDIA PVT LTD	DABIGATRAN ETEXILATE MESYLATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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