Drug Master Files for: MEMANTINE HYDROCHLORIDE

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MEMANTINE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
18436	A	II	6/17/2005	UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)	MEMANTINE HYDROCHLORIDE
18562	A	II	7/29/2005	OLON SPA	MEMANTINE HYDROCHLORIDE
19024	I	II	12/14/2005	ESTEVE QUIMICA SA	MEMANTINE HYDROCHLORIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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