Drug Master Files for: rimantadine hydrochloride

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rimantadine hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10233	I	II	5/5/1993	CILAG AG	RIMANTADINE HYDROCHLORIDE
14936	I	II	6/22/2000	NORTHEAST GENERAL PHARMACEUTICAL FACTORY	RIMANTADINE HYDROCHLORIDE, NON-STERILE BULK DRUG SUBSTANCE CW-100
15210	A	II	12/21/2000	OLAINFARM JSC	RIMANTADINE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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