Drug Master Files for: RIFAMYCIN SODIUM

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RIFAMYCIN SODIUM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11291	A	II	1/9/1995	LUPIN LTD	RIFAMYCIN-S (BULK SUBSTANCE)
11750	I	II	11/16/1995	CKD BIO CORP	RIFAMYCIN-S
11796	I	II	1/22/1996	DIASPA SPA	RIFAMYCIN S BULK
22325	A	II	12/9/2008	LUPIN LTD	RIFAMYCIN O
22907	A	II	6/24/2009	OLON SPA	RIFAMYCIN SV SODUM SALT
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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