APPLICATION
ANDA091444
TYPE
ANDA
ORIGINAL APPROVAL
2014-10-24
LATEST ACTION
2019-05-17
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Discontinued
Products
AZELASTINE HYDROCHLORIDEDiscontinued
AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY · SPRAY, METERED · NASAL
Approval history
2019-05-17Labeling · Supplement 3 · standardAP
2017-01-04Labeling · Supplement 1 · standardAP
2014-10-24OriginalAP
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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