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Last Updated: January 15, 2021

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Drug Master Files for: AZELASTINE HYDROCHLORIDE

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AZELASTINE HYDROCHLORIDE Drug Master Files

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
20186 I II 6/26/2008 CIPLA LTD AZELASTINE HYDROCHLORIDE BP/PH.EUR
20314 A II 2/12/2007 URQUIMA SA AZELASTINE HCL
22427 A II 1/20/2009 ESTEVE QUIMICA SA 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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