Drug Master Files for: amantadine hydrochloride

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amantadine hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
23528	A	II	2/11/2010	OLAINFARM JSC	AMANTADINE HYDROCHLORIDE
25151	A	II	7/21/2011	ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO LTD	AMANTADINE HYDROCHLORIDE USP
2817	I	II	1/7/1977	CILAG CHEMIE AG	AMANTADINE HCL
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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