Drug Master Files for: clarithromycin

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clarithromycin Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14766	I	II	3/10/2000	XIAN PHARMACEUTICAL FACTORY	CLARITHROMYCIN
15276	A	II	2/6/2001	TEVA PHARMACEUTICAL INDUSTRIES LTD	CLARITHROMYCIN USP
15615	I	II	9/6/2001	FERMIC SA DE CV	CLARITHROMYCIN
16083	I	II	8/6/2002	SANDOZ INDUSTRIAL PRODUCTS SA	CLARITHROMYCIN (NON-STERILE BULK)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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