APPLICATION
ANDA081318
TYPE
ANDA
ORIGINAL APPROVAL
1993-04-29
LATEST ACTION
2025-09-26
ROUTE
TOPICAL
DOSAGE FORM
JELLY
MARKETING STATUS
Discontinued
Products
LIDOCAINE HYDROCHLORIDEDiscontinued
LIDOCAINE HYDROCHLORIDE 2% · JELLY · TOPICAL
Approval history
2025-09-26Labeling · Supplement 24 · standardAP
2005-12-06Labeling · Supplement 19AP
2002-02-14Manufacturing (CMC) · Supplement 14AP
2002-02-14Manufacturing (CMC) · Supplement 13AP
2002-01-23Manufacturing (CMC) · Supplement 8AP
2001-10-31Manufacturing (CMC) · Supplement 12AP
2001-10-31Manufacturing (CMC) · Supplement 10AP
2001-10-31Manufacturing (CMC) · Supplement 11AP
2001-02-26Manufacturing (CMC) · Supplement 7AP
1999-03-23Manufacturing (CMC) · Supplement 6AP
1998-11-23Manufacturing (CMC) · Supplement 5AP
1998-07-15Manufacturing (CMC) · Supplement 4AP
1998-05-07Manufacturing (CMC) · Supplement 3AP
1996-05-31Manufacturing (CMC) · Supplement 1AP
1996-05-24Manufacturing (CMC) · Supplement 2AP
1993-04-29OriginalAP
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.