Xylocaine Dental

NDA 21380, held by Dentsply Pharm. Lidocaine Hydrochloride.

As of Nov 14, 2026, NDA 21380 (Xylocaine Dental), held by Dentsply Pharm, was first approved by FDA on Nov 19, 1948, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 19, 1948
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 19, 1948	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Xylocaine Dental2% · injectable;injection	Lidocaine Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Nov 2, 2018	Supplement 7Labeling · Standard review	Approved	Letter Label
Nov 19, 1948	Original application	Approved	None posted

Identifiers

Application: NDA 21380
Drugs@FDA: Overview at FDA
Company: Dentsply Pharmaceutical

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