APPLICATION
ANDA077954
TYPE
ANDA
ORIGINAL APPROVAL
2009-04-30
LATEST ACTION
2019-01-28
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Prescription
Products
AZELASTINE HYDROCHLORIDEPrescription
AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY · SPRAY, METERED · NASAL
Approval history
2019-01-28Labeling · Supplement 11 · standardAP
2016-12-27Labeling · Supplement 6 · standardAP
2013-03-13Labeling · Supplement 4 · 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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