Drug Master Files for: BACLOFEN

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BACLOFEN Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12438	I	II	3/12/1997	PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA	BACLOFEN
12541	A	II	4/17/1997	FINE CHEMICALS CORP PTY LTD	(R)-(-)-BACLOFEN
18014	A	II	1/20/2005	ZAKLADY FARMACEUTYCZNE POLPHARMA SA	BACLOFEN
18220	A	II	3/30/2005	MYLAN LABORATORIES LTD	BACLOFEN USP
20885	A	II	9/25/2007	EXCELLA GMBH AND CO KG	R-BACLOFEN
22881	A	II	6/22/2009	SUMITOMO CHEMICAL CO LTD	R BACLOFEN
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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