APPLICATION
ANDA080429
TYPE
ANDA
ORIGINAL APPROVAL
1974-04-11
LATEST ACTION
2024-11-04
ROUTE
TOPICAL
DOSAGE FORM
JELLY
MARKETING STATUS
Discontinued
Products
ANESTACONDiscontinued
LIDOCAINE HYDROCHLORIDE 2% · JELLY · TOPICAL
Approval history
2024-11-04Labeling · Supplement 19 · standardAP
2024-11-04Labeling · Supplement 21 · standardAP
1996-01-16Manufacturing (CMC) · Supplement 18AP
1992-05-12Manufacturing (CMC) · Supplement 17AP
1991-06-12Labeling · Supplement 14AP
1991-06-05Manufacturing (CMC) · Supplement 13AP
1984-02-16Manufacturing (CMC) · Supplement 11AP
1983-12-13Manufacturing (CMC) · Supplement 10AP
1983-12-08Manufacturing (CMC) · Supplement 7AP
1974-04-11OriginalAP
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.