APPLICATION
ANDA091409
TYPE
ANDA
ORIGINAL APPROVAL
2017-08-14
LATEST ACTION
2021-04-30
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Prescription
Products
AZELASTINE HYDROCHLORIDEPrescription
AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY · SPRAY, METERED · NASAL
Approval history
2021-04-30Labeling · Supplement 1 · standardAP
2017-08-14OriginalAP
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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