Drug Master Files for: MITOXANTRONE HYDROCHLORIDE

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MITOXANTRONE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10858	I	II	4/11/1994	CIPLA LTD	MITOXANTRONE HYDROCHLORIDE
12046	I	II	7/19/1996	SYNTHESIA AS	MITOXANTRONE HYDROCHLORIDE USP
12262	A	II	12/11/1996	CHONGQING CARELIFE PHARMACEUTICAL CO LTD	MITOXANTRONE HYDROCHLORIDE USP
12328	A	II	1/20/1997	IDT AUSTRALIA LTD	MITOXANTRONE HYDROCHLORIDE USP
15879	I	II	2/27/2002	TEVA PHARMACEUTICAL INDUSTRIES LTD	MITOXANTRONE HYDROCHLORIDE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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