APPLICATION
ANDA090423
TYPE
ANDA
ORIGINAL APPROVAL
2012-05-23
LATEST ACTION
2019-04-02
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Discontinued
Products
AZELASTINE HYDROCHLORIDEDiscontinued
AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY · SPRAY, METERED · NASAL
Approval history
2019-04-02Labeling · Supplement 19 · standardAP
2016-12-22Manufacturing (CMC) · Supplement 14 · unknownAP
2016-08-22Labeling · Supplement 9 · standardAP
2012-05-23OriginalAP
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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