← FDA DRUG APPROVALS

FDA ANDA · ANDA208123

CHILDRENS FEXOFENADINE HYDROCHLORIDE ALLERGY

fexofenadine hydrochloride

Sponsor: TARO

APPLICATION
ANDA208123
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-09
LATEST ACTION
2017-11-09
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

2017-11-09UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →