Drug Master Files for: ivacaftor

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ivacaftor Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
28867	A	II	3/10/2015	GLENMARK PHARMACEUTICALS LTD	IVACAFTOR
29398	A	II	5/30/2015	MSN LABORATORIES PRIVATE LTD	IVACAFTOR [ROUTE CODE - 'IC']
31849	A	II	6/30/2017	ALEMBIC PHARMACEUTICALS LTD	IVACAFTOR
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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