Drug Master Files for: RIVAROXABAN

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RIVAROXABAN Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
21580	A	II	7/23/2008	BAYER AG	RIVAROXABAN COATED TABLETS, 10 MG
21581	A	II	7/23/2008	BAYER AG	RIVAROXABAN (MICRONIZED) DRUG SUBSTANCE
21592	A	II	7/24/2008	JANSSEN ORTHO LLC	RIVAROXABAN 10 MG FILM COATED TABLETS
27661	A	II	10/21/2013	ZAKLADY FARMACEUTYCZNE POLPHARMA SA	RIVAROXABAN
27807	A	II	12/31/2013	MSN LABORATORIES PRIVATE LTD	RIVAROXABAN [ROUTE CODE - 'RR']
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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