Drug Master Files for: fidaxomicin

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fidaxomicin Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject

28803	A	II	11/26/2014	BRIGHTGENE BIOMEDICAL TECHNOLOGY CO LTD	FIDAXOMICIN CRYSTALLINE
29374	A	II	9/29/2015	NORTH CHINA PHARMACEUTICAL HUASHENG CO LTD	FIDAXOMICIN
>DMF No.	>Status	>Type	>Submission Date	>Holder	>Subject

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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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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