Drug Master Files for: ROFLUMILAST

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ROFLUMILAST Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
26764	A	II	12/27/2012	SCINOPHARM TAIWAN LTD	ROFLUMILAST
27612	A	II	11/30/2013	MSN LABORATORIES PRIVATE LTD	ROFLUMILAST [ROUTE CODE - RO]
27779	A	II	3/28/2014	ALP PHARM BEIJING CO LTD	ROFLUMILAST
28440	A	II	9/4/2014	MYLAN LABORATORIES LTD	ROFLUMILAST
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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