azelastine / fluticasone Nasal Inhaler

Brand(s)
Dymista
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Meda Pharmaceuticals Inc. (2015-06-18)
Oldest Current Product
2012-05-01
License(s)
NDA
RxNORM
NASAL INHALER\AZELASTINE:FLUTICASONE
FDAOB
NASAL\SPRAY, METERED\AZELASTINE HYDROCHLORIDE: FLUTICASONE PROPIONATE
SPL Active
NASAL\SPRAY, METERED\AZELASTINE HYDROCHLORIDE: FLUTICASONE PROPIONATE
SPL Moiety
NASAL\SPRAY, METERED\AZELASTINE: FLUTICASONE

product(s) by strength(s)

120 actuat azelastine hydrochloride 0.137 mg/actuat / fluticasone propionate 0.05 mg/actuat nasal inhaler

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000370245DymistaNDAMeda Pharmaceuticals Inc.2012-05-01AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATENASALSPRAY, METEREDNDA2022364c557ec4-c4cf-11df-851a-0800200c9a66

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202236DYMISTAMEDA PHARMACEUTICALS2012-05-01p8168620, SUBSTANCE
p8163723, ALLERGIC RHINITIS/ RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS/ TREATMENT OF SEASONAL ALLERGIC RHINITIS/ TREATMENT OF SYMPTOMS OF SEASONAL ALLERGIC RHINITIS/ TREATMENT OF ALLERGIC RHINITIS
NEW PATIENT POPULATION [2018-02-20]
NEW COMBINATION [2015-05-01]
NDA202236_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202236_001RXFLUTICASONE PROPIONATE (0.05MG/SPRAY), AZELASTINE HYDROCHLORIDE (EQ 0.125MG BASE/SPRAY)NASALSPRAY, METEREDTrue2012-05-01DYMISTA

patent(s)

#idexpiration dateapplication(s)
1p8163723 (view patent)2023-08-29NDA202236
2p8168620 (view patent)2026-02-24NDA202236

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
14c557ec4-c4cf-11df-851a-0800200c9a66 (view SPL)These highlights do not include all the information needed to use DYMISTA safely and effectively. See full prescribing information for DYMISTA. DYMISTA (azelastine hydrochloride and fluticasone propionate) nasal spray, for intranasal use Initial U.S. Approval: 2012prescriptionHuman PrescriptionMeda Pharmaceuticals Inc.2015-06-189000370245

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII