Drug Master Files for: epirubicin hydrochloride

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epirubicin hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16258	A	II	10/31/2002	SYNBIAS PHARMA AG	EPIRUBICIN HYDROCHLORIDE
16324	A	II	12/18/2002	ZHEJIANG HISUN PHARMACEUTICAL CO LTD	EPIRUBICIN HYDROCHLORIDE
18307	A	II	4/26/2005	TEVA PHARMACEUTICAL INDUSTRIES LTD	EPIRUBICIN HYDROCHLORIDE LYOPHILIZED
18498	I	II	7/6/2005	ZHEJIANG HISUN PHARMACEUTICAL CO LTD	EPIRUBICIN HYDROCHLORIDE (LYOPHILIZED) NON-STERILE A PHARMACEUTICAL INGREDIENT
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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