Drug Master Files for: BEXAROTENE

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BEXAROTENE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
23545	I	II	3/16/2010	USV LTD	BEXAROTENE
23631	A	II	4/26/2010	APICORE US LLC	BEXAROTENE
25542	A	II	11/29/2011	AVANTHERA SA	BEXAROTENE
28944	A	II	12/22/2014	HETERO LABS LTD	BEXAROTENE
30077	A	II	1/13/2016	MSN LABORATORIES PRIVATE LTD	BEXAROTENE [ROUTE CODE BX]
31580	A	II	4/5/2017	TIANJIN WEIJIE PHARMACEUTICAL CO LTD	BEXAROTENE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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