APPLICATION
ANDA078367
TYPE
ANDA
ORIGINAL APPROVAL
2010-07-12
LATEST ACTION
2019-10-22
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription
Products
DESLORATADINEPrescription
DESLORATADINE 2.5MG · TABLET, ORALLY DISINTEGRATING · ORAL
DESLORATADINEPrescription
DESLORATADINE 5MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2019-10-22Labeling · Supplement 5 · standardAP
2015-02-11Labeling · Supplement 2 · standardAP
2011-11-18Labeling · Supplement 1AP
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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