Drug Master Files for: busulfan

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busulfan Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
21126	A	II	12/12/2007	CHEMPACIFIC CORP	BUSULFAN DRUG SUBSTANCE
23924	A	II	8/5/2010	APICORE US LLC	BUSULFAN USP
24385	A	II	11/30/2010	FRESENIUS KABI ONCOLOGY LTD	BUSULFAN
25393	I	II	10/18/2011	EUTICALS SPA	BUSULFAN
25433	A	II	12/29/2011	EMCURE PHARMACEUTICALS LTD	BUSULFAN 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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