Drug Master Files for: ambrisentan

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ambrisentan Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
24505	A	II	12/21/2010	MYLAN LABORATORIES LTD	AMBRISENTAN
25134	I	II	9/9/2011	WATSON PHARMA PRIVATE LTD	AMBRISENTAN
26156	A	II	6/8/2012	MSN LABORATORIES PRIVATE LTD	AMBRISENTAN [ROUTE CODE - AB]
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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