APPLICATION
NDA014127
TYPE
NDA
ORIGINAL APPROVAL
1964-03-11
LATEST ACTION
1996-05-31
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
XYLOCAINEDiscontinued
LIDOCAINE 5% · SOLUTION · TOPICAL
Approval history
1996-05-31Manufacturing (CMC) · Supplement 7 · priorityAP
1993-02-18Manufacturing (CMC) · Supplement 6 · priorityAP
1987-09-16Manufacturing (CMC) · Supplement 5 · priorityAP
1985-03-25Labeling · Supplement 2 · priorityAP
1984-06-20Manufacturing (CMC) · Supplement 4 · priorityAP
1982-03-25Manufacturing (CMC) · Supplement 3 · priorityAP
1964-03-11Type 3 - New Dosage Form · Original · priorityAP
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.