Drug Master Files for: APREMILAST

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APREMILAST Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
30248	A	II	4/6/2016	LUPIN LTD	APREMILAST
30332	A	II	3/29/2016	MSN LIFE SCIENCES PRIVATE LTD	APREMILAST [ROUTE CODE LI]
30732	A	II	9/30/2016	DR REDDYS LABORATORIES LTD	APREMILAST (FORM B)
30866	A	II	8/31/2016	MSN LIFE SCIENCES PRIVATE LTD	APREMILAST (FORM-M)
31141	A	II	11/9/2016	ZAKLADY FARMACEUTYCZNE POLPHARMA SA	APREMILAST
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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