Drug Master Files for: TRABECTEDIN

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TRABECTEDIN Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
21642	I	II	5/16/2008	LONZA AG	ETH06 (TRABECTEDIN DRUG SUBSTANCE INTERMEDIATE)
21755	A	II	6/23/2008	PHARMA MAR SA	TRABECTEDIN
22020	I	II	11/12/2008	JANSSEN PHARMACEUTICA NV	TRABECTEDIN (R279741)
27694	A	II	10/31/2013	LONZA AG	ETH06 (TRABECTEDIN INTERMEDIATE)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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