APPLICATION
NDA008816
TYPE
NDA
ORIGINAL APPROVAL
1953-03-12
LATEST ACTION
2025-04-01
ROUTE
TOPICAL
DOSAGE FORM
JELLY
MARKETING STATUS
Discontinued
Products
XYLOCAINE · ReferenceDiscontinued
LIDOCAINE HYDROCHLORIDE 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · JELLY · TOPICAL
Approval history
2013-10-24Manufacturing (CMC) · Supplement 38 · standardAP
2013-09-24Manufacturing (CMC) · Supplement 37 · standardAP
2012-11-28Manufacturing (CMC) · Supplement 36 · standardAP
2000-06-02Manufacturing (CMC) · Supplement 31 · standardAP
1999-07-29Manufacturing (CMC) · Supplement 30 · standardAP
1998-04-07Manufacturing (CMC) · Supplement 28 · standardAP
1996-05-31Manufacturing (CMC) · Supplement 29 · standardAP
1993-02-18Manufacturing (CMC) · Supplement 27 · standardAP
1990-11-07Manufacturing (CMC) · Supplement 24 · standardAP
1987-09-16Manufacturing (CMC) · Supplement 15 · standardAP
1987-06-08Manufacturing (CMC) · Supplement 17 · standardAP
1987-06-08Manufacturing (CMC) · Supplement 16 · standardAP
1984-11-20Labeling · Supplement 8AP
1984-07-11Labeling · Supplement 13AP
1984-07-11Manufacturing (CMC) · Supplement 12 · standardAP
1984-06-20Manufacturing (CMC) · Supplement 14 · standardAP
1982-03-25Manufacturing (CMC) · Supplement 9 · standardAP
1981-02-23Labeling · Supplement 7AP
1981-02-23Efficacy · Supplement 6AP
1979-02-16Manufacturing (CMC) · Supplement 5 · standardAP
1977-02-02Labeling · Supplement 4AP
1977-02-02Labeling · Supplement 2AP
1977-01-12Manufacturing (CMC) · Supplement 3 · standardAP
1973-03-06Labeling · Supplement 1AP
1953-03-12Type 3 - New Dosage Form · Original · standardAP
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.
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