Drug Master Files for: TIZANIDINE HYDROCHLORIDE

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TIZANIDINE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15525	A	II	7/4/2001	FARMAK AS	TIZANIDINE HCL
15555	I	II	7/30/2001	FARCHEMIA SRL	TIZANIDINE HYDROCHLORIDE
15699	A	II	11/2/2001	DR REDDYS LABORATORIES LTD	TIZANIDINE HYDROCHLORIDE USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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