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FDA ANDA · ANDA078357

DESLORATADINE

Sponsor: ORBION PHARMS

APPLICATION
ANDA078357
TYPE
ANDA
ORIGINAL APPROVAL
2010-02-19
LATEST ACTION
2019-10-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DESLORATADINEPrescription
DESLORATADINE 5MG · TABLET · ORAL

Approval history

2019-10-18Labeling · Supplement 5 · standardAP
2015-02-11Labeling · Supplement 4 · standardAP
2013-12-20Labeling · Supplement 1AP
2010-02-19OriginalLetterAP
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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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