Drug Master Files for: DANTROLENE SODIUM

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DANTROLENE SODIUM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15167	A	II	11/28/2000	JINAN JINDA PHARMACEUTICAL CHEMISTRY CO LTD	DANTROLENE SODIUM NON-STERILE BULK DRUG SUBSTANCE
16118	A	II	8/23/2002	SCINOPHARM TAIWAN LTD	DANTROLENE SODIUM USP
17446	I	II	5/27/2004	FDC LTD	DANTROLENE SODIUM
19498	A	II	6/1/2006	HELSINN ADVANCED SYNTHESIS SA	DANTROLENE SODIUM DRUG SUBSTANCE
20779	A	II	8/16/2007	JOHNSON MATTHEY PHARMACEUTICAL MATERIALS	DANTROLENE SODIUM (DTE)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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