APPLICATION
ANDA201846
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-31
LATEST ACTION
2019-11-04
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Discontinued
Products
AZELASTINE HYDROCHLORIDEDiscontinued
AZELASTINE HYDROCHLORIDE 0.2055MG/SPRAY · SPRAY, METERED · NASAL
Approval history
2019-11-04Labeling · Supplement 8 · standardAP
2017-01-05Labeling · Supplement 5 · standardAP
2017-01-05Labeling · Supplement 1 · 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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