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FDA ANDA · ANDA207712
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
Sponsor: APOTEX
APPLICATION
ANDA207712
TYPE
ANDA
ORIGINAL APPROVAL
2017-04-28
LATEST ACTION
2026-07-01
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
2026-07-01Labeling · Supplement 13 · standardAP
2022-11-01Labeling · Supplement 5 · standardAP
2022-11-01Labeling · Supplement 1 · standardAP
2020-11-25Manufacturing (CMC) · Supplement 4 · unknownAP
2017-04-28UNKNOWN · 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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