Xylocaine

NDA 8816, held by Epic Pharma LLC. Lidocaine Hydrochloride.

As of Nov 14, 2026, NDA 8816 (Xylocaine), held by Epic Pharma LLC, was first approved by FDA on Mar 12, 1953, with 27 approved supplements and 0 published complete response letters.

First approved: Mar 12, 1953
Review: Standard
Supplements approved: 27
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below


Feb 23, 1981	Supplement 6Efficacy (new indication or use)	Approved	None posted
Mar 12, 1953	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Xylocaine2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · jelly;topical	Lidocaine Hydrochloride	DiscontinuedReference drug

All 28 submissions, including labeling and manufacturing supplements


Apr 1, 2025	Supplement 40Labeling · Standard review	Approved	Letter Label
Nov 2, 2018	Supplement 39Labeling · Standard review	Approved	Letter Label
Oct 24, 2013	Supplement 38Manufacturing · Standard review	Approved	None posted
Sep 24, 2013	Supplement 37Manufacturing · Standard review	Approved	None posted
Nov 28, 2012	Supplement 36Manufacturing · Standard review	Approved	None posted
Jul 23, 2004	Supplement 32Labeling · Standard review	Approved	Letter Label
Jun 2, 2000	Supplement 31Manufacturing · Standard review	Approved	None posted
Jul 29, 1999	Supplement 30Manufacturing · Standard review	Approved	None posted
Apr 7, 1998	Supplement 28Manufacturing · Standard review	Approved	None posted
May 31, 1996	Supplement 29Manufacturing · Standard review	Approved	None posted
Feb 18, 1993	Supplement 27Manufacturing · Standard review	Approved	None posted
Nov 7, 1990	Supplement 24Manufacturing · Standard review	Approved	None posted
Sep 16, 1987	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 8, 1987	Supplement 17Manufacturing · Standard review	Approved	None posted
Jun 8, 1987	Supplement 16Manufacturing · Standard review	Approved	None posted
Nov 20, 1984	Supplement 8Labeling	Approved	None posted
Jul 11, 1984	Supplement 13Labeling	Approved	None posted
Jul 11, 1984	Supplement 12Manufacturing · Standard review	Approved	None posted
Jun 20, 1984	Supplement 14Manufacturing · Standard review	Approved	None posted
Mar 25, 1982	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 23, 1981	Supplement 7Labeling	Approved	None posted
Feb 23, 1981	Supplement 6Efficacy (new indication or use)	Approved	None posted
Feb 16, 1979	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 2, 1977	Supplement 4Labeling	Approved	None posted
Feb 2, 1977	Supplement 2Labeling	Approved	None posted
Jan 12, 1977	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 6, 1973	Supplement 1Labeling	Approved	None posted
Mar 12, 1953	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 8816
Drugs@FDA: Overview at FDA
Company: Epic Pharma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters