Drug Master Files for: DOLASETRON MESYLATE

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DOLASETRON MESYLATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
21852	A	II	7/31/2008	ROLABO OUTSOURCING SL	DOLASETRON MESYLATE
24145	I	II	9/23/2010	USV LTD	DOLASETRON MESYLATE USP
24531	I	II	1/6/2011	APOTEX PHARMACHEM INDIA PVT LTD	DOLASETRON MESYLATE MONOHYDRATE USP
24794	A	II	3/28/2011	EMCURE PHARMACEUTICALS LTD	DOLASETRON MESYLATE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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