Drug Master Files for: epinastine hydrochloride

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epinastine hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15003	A	II	9/11/2000	BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG	EPINASTINE HYDROCHLORIDE
20993	A	II	11/2/2007	EXCELLA GMBH AND CO KG	EPINASTINE HYDROCHLORIDE
21830	A	II	7/28/2008	ICROM SPA	EPINASTINE HYDROCHLORIDE
21851	A	II	8/1/2008	TRIFARMA SPA	EPINASTINE HYDROCHLORIDE
21974	A	II	12/30/2008	CHEMWERTH INC	EPINASTINE HCL
22854	A	II	6/22/2009	SUN PHARMACEUTICAL INDUSTRIES LTD	EPINASTINE HYDROCHLORIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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