Drug Master Files for: APIXABAN

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APIXABAN Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
28009	A	II	2/26/2014	MSN LABORATORIES PRIVATE LTD	APIXABAN [ROUTE CODE AX]
29660	A	II	9/30/2015	ALEMBIC PHARMACEUTICALS LTD	APIXABAN
29667	A	II	9/2/2015	ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD	APIXABAN
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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