Drug Master Files for: DAUNORUBICIN HYDROCHLORIDE

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DAUNORUBICIN HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11879	A	II	2/29/1996	MICROBIOPHARM JAPAN CO LTD	DAUNORUBICIN HYDROCHLORIDE (CRUDE)
13503	I	II	9/1/1998	RHONE POULENC RORER PHARMACEUTICALS INC	DAUNORUBICIN HYDROCHLORIDE
13727	A	II	9/1/1998	MEIJI SEIKA PHARMA CO LTD	DAUNORUBICIN HYDROCHLORIDE (DRUG SUBSTANCE)
13775	A	II	9/1/1998	ZHEJIANG HISUN PHARMACEUTICAL CO LTD	DAUNORUBICIN HYDROCHLORIDE USP
13786	A	II	9/1/1998	TEVA PHARMACEUTICAL INDUSTRIES LTD	DAUNORUBICIN HYDROCHLORIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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