Drug Master Files for: AZITHROMYCIN

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AZITHROMYCIN Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14079	I	II	4/15/1999	PLIVA DD	MANUFACTURING SITE, PERSONNEL, AND OPERATING PROCEDURES FOR AZITHROMYCIN DIHYDRATE
14480	I	II	10/14/1999	WOCKHARDT LTD	AZITHROMYCIN USP
15261	A	II	1/24/2001	TEVA PHARMACEUTICAL INDUSTRIES LTD	AZITHROMYCIN MONOHYDRATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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