Drug Master Files for: DOXORUBICIN HYDROCHLORIDE

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DOXORUBICIN HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
13136	I	V	10/9/1998	PHARMACIA AND UPJOHN	TOXICOLOGY INFORMATION FOR IODODOXORUBICIN HCL
13209	A	II	4/30/1998	MEIJI SEIKA PHARMA CO LTD	DOXORUBICIN HYDROCHLORIDE DRUG SUBSTANCE
13211	A	II	4/30/1998	MICROBIOPHARM JAPAN CO LTD	DOXORUBICIN HYDROCHLORIDE
13726	A	II	9/1/1998	TEVA PHARMACEUTICAL INDUSTRIES LTD	DOXORUBICIN HYDROCHLORIDE
13773	A	II	9/1/1998	ZHEJIANG HISUN PHARMACEUTICAL CO LTD	DOXORUBICIN 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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