Lidocaine Hydrochloride

NDA 17508, held by Abraxis Pharm. Lidocaine Hydrochloride.

As of Nov 14, 2026, NDA 17508 (Lidocaine Hydrochloride), held by Abraxis Pharm, was first approved by FDA on Oct 27, 1976, with 6 approved supplements and 0 published complete response letters.

First approved: Oct 27, 1976
Review: Standard
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
Oct 27, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

3 strengths and forms


Lidocaine Hydrochloride2% · injectable;injection	Lidocaine Hydrochloride	Discontinued
Lidocaine Hydrochloride4% · injectable;injection	Lidocaine Hydrochloride	Discontinued
Lidocaine Hydrochloride20% · injectable;injection	Lidocaine Hydrochloride	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Dec 7, 1987	Supplement 19Labeling	Approved	None posted
Dec 13, 1982	Supplement 8Labeling	Approved	None posted
Mar 2, 1981	Supplement 10Labeling	Approved	None posted
Jan 8, 1980	Supplement 5Labeling	Approved	None posted
Jul 10, 1979	Supplement 3Labeling	Approved	None posted
Nov 1, 1978	Supplement 1Labeling	Approved	None posted
Oct 27, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17508
Drugs@FDA: Overview at FDA
Company: Abraxis Pharmaceuticals

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