APPLICATION
ANDA078364
TYPE
ANDA
ORIGINAL APPROVAL
2010-12-03
LATEST ACTION
2019-10-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DESLORATADINEDiscontinued
DESLORATADINE 5MG · TABLET · ORAL
Approval history
2019-10-22Labeling · Supplement 10 · standardAP
2015-02-13Labeling · Supplement 9 · standardAP
2014-01-09Labeling · Supplement 1 · standardAP
2010-12-03OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.