Drug Master Files for: DIRITHROMYCIN

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DIRITHROMYCIN Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
18393	I	II	5/11/2005	CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY CO LTD	DIRITHROMYCIN USP, NON-STERILE DRUG SUBSTANCE
20584	A	II	4/30/2007	HUNAN JIUDIAN PHARMACEUTICAL CO LTD	DIRITHROMYCIN
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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