Drug Master Files for: DONEPEZIL HYDROCHLORIDE

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DONEPEZIL HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15694	A	II	10/29/2001	FINETECH PHARMACEUTICAL LTD	DONEPEZIL HYDROCHLORIDE
16674	I	II	6/30/2003	SUN PHARMACEUTICAL INDUSTRIES LTD	DONEPEZIL HYDROCHLORIDE (MONOHYDRATE) USP
17523	I	II	7/8/2004	PERRIGO API LTD	DONEPEZIL HYDROCHLORIDE (DILUTED) 25% AMORPHOUS
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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