Drug Master Files for: AZELASTINE HYDROCHLORIDE

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AZELASTINE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15361	A	II	3/29/2001	GEDEON RICHTER PLC	AZELASTINE HCL USP
15440	A	II	5/15/2001	EVONIK NUTRITION AND CARE GMBH	AZELASTINE HYDROCHLORIDE
18398	A	II	6/1/2005	DAITO PHARMACEUTICALS CO LTD	AZELASTINE HYDROCHLORIDE USP
19422	A	II	5/5/2006	EUTICALS SPA	AZELASTINE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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