Xylocaine

NDA 8048, held by Astrazeneca. Lidocaine.

As of Nov 14, 2026, NDA 8048 (Xylocaine), held by Astrazeneca, was first approved by FDA on May 17, 1951, with 14 approved supplements and 0 published complete response letters.

First approved: May 17, 1951
Review: Standard
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
May 17, 1951	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Xylocaine5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · ointment;topical	Lidocaine	DiscontinuedReference drug

All 15 submissions, including labeling and manufacturing supplements


Dec 4, 2000	Supplement 17Manufacturing · Standard review	Approved	None posted
May 31, 1996	Supplement 14Manufacturing · Standard review	Approved	None posted
May 2, 1996	Supplement 15Manufacturing · Standard review	Approved	None posted
May 2, 1996	Supplement 16Manufacturing · Standard review	Approved	None posted
Feb 18, 1993	Supplement 13Manufacturing · Standard review	Approved	None posted
Jul 11, 1991	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 27, 1990	Supplement 11Manufacturing · Standard review	Approved	None posted
Sep 16, 1987	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 7, 1987	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 24, 1986	Supplement 8Labeling · Standard review	Approved	None posted
Nov 21, 1985	Supplement 5Labeling · Standard review	Approved	None posted
Jun 15, 1984	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 25, 1982	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 16, 1980	Supplement 4Labeling · Standard review	Approved	None posted
May 17, 1951	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 8048
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

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