APPLICATION
ANDA075209
TYPE
ANDA
ORIGINAL APPROVAL
2003-01-21
LATEST ACTION
2010-03-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
LORATADINEOver-the-counter
LORATADINE 10MG · TABLET · ORAL
Approval history
2010-03-10Manufacturing (CMC) · Supplement 19AP
2009-03-20Labeling · Supplement 18AP
2003-10-29Labeling · Supplement 2AP
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.