Lidocaine

Relieves pain associated with minor burns, including sunburn, abrasions of the skin, and…. ANDA 86724, held by Sun Pharma Canada. Lidocaine.

As of Nov 15, 2026, ANDA 86724 (Lidocaine), held by Sun Pharma Canada, was first approved by FDA on Aug 17, 1981, with 15 approved supplements and 0 published complete response letters.

First approved: Aug 17, 1981
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Lidocaine Ointment USP, 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Aug 17, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lidocaine5% · ointment;topical	Lidocaine	Rx

All 16 submissions, including labeling and manufacturing supplements


Nov 2, 2018	Supplement 33Labeling · Standard review	Approved	None posted
Nov 2, 2018	Supplement 35Labeling · Standard review	Approved	None posted
Sep 2, 2016	Supplement 28Manufacturing	Approved	None posted
Jan 24, 2006	Supplement 20Labeling	Approved	None posted
Feb 16, 1993	Supplement 14Labeling	Approved	None posted
Sep 22, 1989	Supplement 13Labeling	Approved	None posted
Jun 30, 1989	Supplement 12Manufacturing	Approved	None posted
Feb 24, 1989	Supplement 11Manufacturing	Approved	None posted
Aug 14, 1986	Supplement 9Manufacturing	Approved	None posted
Feb 25, 1986	Supplement 5Manufacturing	Approved	None posted
Feb 25, 1986	Supplement 6Manufacturing	Approved	None posted
Feb 25, 1986	Supplement 7Manufacturing	Approved	None posted
Jun 12, 1984	Supplement 4Manufacturing	Approved	None posted
Apr 5, 1982	Supplement 2Manufacturing	Approved	None posted
Mar 24, 1982	Supplement 1Manufacturing	Approved	None posted
Aug 17, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 86724
Drugs@FDA: Overview at FDA
Company: Sun Pharma Canada

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