Drug Master Files for: BOSENTAN

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BOSENTAN Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
23255	A	II	11/11/2009	MSN LABORATORIES PRIVATE LTD	BOSENTAN MONOHYDRATE [ROUTE CODE - 'BN']
23354	A	II	12/4/2009	MYLAN LABORATORIES LTD	BOSENTAN
23455	A	II	1/14/2010	AMINO CHEMICALS LTD	BOSENTAN MONOHYDRATE
23817	I	II	12/23/2010	SUN PHARMACEUTICAL INDUSTRIES LTD	BOSENTAN MONOHYDRATE
24124	A	II	9/9/2010	GLENMARK PHARMACEUTICALS LTD	BOSENTAN
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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