Last Updated: November 8, 2026

Drug Master Files for: ROTIGOTINE

ROTIGOTINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
25863	I	II	3/7/2012	OLON SPA	ROTIGOTINE
26236	A	II	7/12/2012	WAVELENGTH ENTERPRISES LTD	ROTIGOTINE
26481	A	II	9/26/2012	INTERQUIM SA	ROTIGOTINE
27370	A	II	8/30/2013	MYLAN LABORATORIES LTD	ROTIGOTINE
27554	A	II	9/13/2013	OLON USA INC	ROTIGOTINE POLYMORPH II
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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