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FDA NDA · NDA021963

ALLEGRA

Sponsor: CHATTEM SANOFI

APPLICATION
NDA021963
TYPE
NDA
ORIGINAL APPROVAL
2006-10-16
LATEST ACTION
2019-05-30
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued

Products

ALLEGRA · ReferenceDiscontinued
FEXOFENADINE HYDROCHLORIDE 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUSPENSION · ORAL

Approval history

2019-05-30Labeling · Supplement 7 · standardLabelAP
2008-06-25Labeling · Supplement 2 · standardLabelAP
2006-10-16Type 3 - New Dosage Form · Original · standardLabelAP
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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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