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ACTIVE SUBSTANCE / INN

AZELASTINE HYDROCHLORIDE

Brand name(s): DYMISTA, CHILDREN'S ASTEPRO ALLERGY, AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY, AZELASTINE HYDROCHLORIDE ALLERGY, ASTEPRO, AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE, AZELASTINE HYDROCHLORIDE, ASTELIN, ASTEPRO ALLERGY
FDA LISTED
PRESCRIPTION
OVER-THE-COUNTER
DISCONTINUED
ANDA216421
NDA022203
ACTIVE SUBSTANCE
Azelastine Hydrochloride
REGULATORS
FDA
SPONSORS / MAH
VIATRIS, SANDOZ, RISING
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
AZELASTINE HYDROCHLORIDEANDA202305SANDOZPrescription
ASTEPRO ALLERGYNDA213872BAYER HLTHCAREOver-the-counter
CHILDREN'S ASTEPRO ALLERGYNDA213872BAYER HLTHCAREOver-the-counter
AZELASTINE HYDROCHLORIDEANDA090176BIONPHARMADiscontinued
AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGYANDA216421APOTEXOver-the-counter
AZELASTINE HYDROCHLORIDE ALLERGYANDA216421APOTEXOver-the-counter
ASTEPRONDA022203VIATRISDiscontinued
DYMISTANDA202236MYLAN SPECIALITY LPPrescription
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEANDA207712APOTEXPrescription
ASTELINNDA020114RISINGDiscontinued

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