Xylocaine

NDA 14127, held by Astrazeneca. Lidocaine.

As of Nov 13, 2026, NDA 14127 (Xylocaine), held by Astrazeneca, was first approved by FDA on Mar 11, 1964, with 6 approved supplements and 0 published complete response letters.

First approved: Mar 11, 1964
Review: Priority
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Mar 11, 1964	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Xylocaine5% · solution;topical	Lidocaine	Discontinued

All 7 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 31, 1996	Supplement 7Manufacturing · Priority review	Approved	None posted
Feb 18, 1993	Supplement 6Manufacturing · Priority review	Approved	None posted
Sep 16, 1987	Supplement 5Manufacturing · Priority review	Approved	None posted
Mar 25, 1985	Supplement 2Labeling · Priority review	Approved	None posted
Jun 20, 1984	Supplement 4Manufacturing · Priority review	Approved	None posted
Mar 25, 1982	Supplement 3Manufacturing · Priority review	Approved	None posted
Mar 11, 1964	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 14127
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