Drug Master Files for: rifaximin

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rifaximin Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12352	I	II	2/6/1997	PHARMACEUTICAL FINE CHEMICALS PFC BAHAMAS LTD	RIFAXIMIN
15635	A	II	9/20/2001	FIS FABBRICA ITALIANA SINTETICI SPA	RIFAXIMIN
17150	A	II	2/10/2004	SANOFI SPA	RIFAXIMIN
17974	A	II	12/14/2004	OLON SPA	RIFAXIMIN
20436	A	II	3/31/2007	LUPIN LTD	RIFAXIMIN
28096	A	II	3/28/2014	MSN LABORATORIES PRIVATE LTD	RIFAXIMIN [ROUTE CODE RX]
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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