← FDA DRUG APPROVALS

FDA ANDA · ANDA078447

LORATADINE

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA078447
TYPE
ANDA
ORIGINAL APPROVAL
2011-08-12
LATEST ACTION
2011-08-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LORATADINEDiscontinued
LORATADINE 10MG · TABLET · ORAL

Approval history

2011-08-12OriginalAP
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 →