Drug Master Files for: TIAGABINE HYDROCHLORIDE

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TIAGABINE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
17978	A	II	1/6/2005	SUN PHARMACEUTICAL INDUSTRIES LTD	TIAGABINE HYDROCHLORIDE USP
18934	I	II	11/4/2005	RANBAXY LABORATORIES LTD	TIAGABINE HYDROCHLORIDE USP
22033	A	II	9/23/2008	CHEMWERTH INC	TIAGABINE HYDROCHLORIDE
27286	I	II	8/26/2013	UNICHEM LABORATORIES LTD	TIAGABINE HYDROCHLORIDE USP
27380	A	II	12/20/2013	SIGNA SA DE CV	TIAGABINE HYDROCHLORIDE MONOHYDRATE USP
33494	A	II	12/31/2018	MSN LIFE SCIENCES PRIVATE LTD	TIAGABINE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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