← FDA DRUG APPROVALS
FDA ANDA · ANDA208111
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
azelastine hydrochloride, fluticasone propionate
Sponsor: PADAGIS ISRAEL
APPLICATION
ANDA208111
TYPE
ANDA
ORIGINAL APPROVAL
2021-02-18
LATEST ACTION
2026-06-03
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Prescription
Products
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATEPrescription
AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY, FLUTICASONE PROPIONATE 0.05MG/SPRAY · SPRAY, METERED · NASAL
Approval history
2026-06-03Labeling · Supplement 11 · standardAP
2023-06-12Labeling · Supplement 5 · standardAP
2021-02-18UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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