Drug Master Files for: MACITENTAN

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MACITENTAN Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
30212	A	II	1/30/2016	MSN LIFE SCIENCES PRIVATE LTD	MACITENTAN [ROUTE CODE IM]
30969	A	II	9/30/2016	MYLAN LABORATORIES LTD	MACITENTAN
31179	A	II	12/13/2016	RAKS PHARMA PVT LTD	MACITENTAN
31213	A	II	1/5/2017	HONOUR LAB LTD	MACITENTAN
31416	A	II	4/13/2017	TEVA PHARMACEUTICAL INDUSTRIES LTD	MACITENTAN
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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