Drug Master Files for: BEPOTASTINE BESILATE

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BEPOTASTINE BESILATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
19966	A	II	11/15/2006	UBE INDUSTRIES LTD	BEPOTASTINE BESILATE
27170	I	II	7/3/2013	MEDICHEM MANUFACTURING MALTA LTD	BEPOTASTINE BESILATE
27350	A	II	8/14/2013	BAL PHARMA LTD	BEPOTASTINE BESILATE
27386	A	II	8/16/2013	BAL PHARMA LTD	BEPOTASTINE BESILATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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