APPLICATION
ANDA080198
TYPE
ANDA
ORIGINAL APPROVAL
1972-06-30
LATEST ACTION
2018-11-02
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription
Products
LIDOCAINE · ReferencePrescription
LIDOCAINE 5% · OINTMENT · TOPICAL
Approval history
2018-11-02Labeling · Supplement 30 · standardAP
2000-11-14Manufacturing (CMC) · Supplement 21AP
1996-03-07Manufacturing (CMC) · Supplement 20AP
1995-11-20Manufacturing (CMC) · Supplement 19AP
1987-12-11Manufacturing (CMC) · Supplement 17AP
1983-05-09Manufacturing (CMC) · Supplement 15AP
1972-06-30OriginalAP
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.