Drug Master Files for: safinamide

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safinamide Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
28157	A	II	6/12/2014	MERCK KGAA	SAFINAMIDE METHANESULFONATE
32225	A	II	2/7/2018	FIS FABBRICA ITALIANA SINTETICI SPA	SAFINAMIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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