APPLICATION
ANDA203330
TYPE
ANDA
ORIGINAL APPROVAL
2014-11-18
LATEST ACTION
2020-03-03
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Over-the-counter
Products
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYOver-the-counter
FEXOFENADINE HYDROCHLORIDE 30MG/5ML · SUSPENSION · ORAL
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESOver-the-counter
FEXOFENADINE HYDROCHLORIDE 30MG/5ML · SUSPENSION · ORAL
Approval history
2020-03-03Labeling · Supplement 5 · standardAP
2014-11-18UNKNOWN · OriginalAP
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.