Drug Master Files for: BRETYLIUM TOSYLATE

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BRETYLIUM TOSYLATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
25937	A	II	4/20/2012	TOPCHEM PHARMACEUTICALS LTD	BRETYLIUM TOSYLATE
2729	I	II	9/3/1976	GANES CHEMICALS INC PENNSVILLE DIV	BRETYLIUM TOSYLATE
3361	I	II	11/20/1978	DELMAR CHEMICALS INC	BRETYLIUM TOSYLATE, BULK FORM
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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