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FDA ANDA · ANDA208436

AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE

Sponsor: TEVA PHARMS USA INC

APPLICATION
ANDA208436
TYPE
ANDA
ORIGINAL APPROVAL
2025-04-08
LATEST ACTION
2025-04-08
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

2025-04-08UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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