Lidocaine Hydrochloride Preservative Free

NDA 17584, held by Fresenius Kabi USA. Lidocaine Hydrochloride.

As of Nov 13, 2026, NDA 17584 (Lidocaine Hydrochloride Preservative Free), held by Fresenius Kabi USA, was first approved by FDA on Mar 26, 1976, with 26 approved supplements and 0 published complete response letters.

First approved: Mar 26, 1976
Review: Standard
Supplements approved: 26
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS & USAGE Lidocaine Hydrochloride Injection, USP administered intravenously is specifically indicated in the acute management of 1) ventricular arrhythmias occurring during cardiac manipulation such as cardiac surgery, and 2) life-threatening arrhythmias, particularly those which are ventricular in origin, such as those which occur during acute myocardial infarction.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
Mar 26, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Lidocaine Hydrochloride Preservative Free2% · injectable;injection	Lidocaine Hydrochloride	Rx
Lidocaine Hydrochloride Preservative Free4% · injectable;injection	Lidocaine Hydrochloride	Rx

All 27 submissions, including labeling and manufacturing supplements


Aug 17, 2026	Supplement 44Labeling · Standard review	Approved	Label Letter
Sep 13, 1996	Supplement 28Labeling · Standard review	Approved	None posted
Dec 19, 1995	Supplement 25Manufacturing · Standard review	Approved	None posted
Dec 19, 1995	Supplement 24Manufacturing · Standard review	Approved	None posted
Aug 5, 1994	Supplement 19Labeling	Approved	None posted
May 17, 1993	Supplement 27Labeling · Standard review	Approved	None posted
Aug 23, 1991	Supplement 22Manufacturing · Standard review	Approved	None posted
Apr 7, 1987	Supplement 21Manufacturing · Standard review	Approved	None posted
May 22, 1986	Supplement 16Labeling	Approved	None posted
Feb 24, 1986	Supplement 18Manufacturing · Standard review	Approved	None posted
Feb 14, 1986	Supplement 15Labeling	Approved	None posted
Apr 30, 1985	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 31, 1984	Supplement 17Manufacturing · Standard review	Approved	None posted
Dec 8, 1982	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 21, 1982	Supplement 13Labeling	Approved	None posted
Feb 5, 1981	Supplement 11Manufacturing · Standard review	Approved	None posted
Jan 9, 1980	Supplement 10Labeling	Approved	None posted
Jul 10, 1979	Supplement 9Manufacturing · Standard review	Approved	None posted
May 26, 1978	Supplement 5Manufacturing · Standard review	Approved	None posted
May 26, 1978	Supplement 4Labeling	Approved	None posted
Dec 1, 1977	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 1, 1977	Supplement 7Manufacturing · Standard review	Approved	None posted
Jul 12, 1977	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 29, 1976	Supplement 3Labeling	Approved	None posted
Aug 18, 1976	Supplement 2Labeling	Approved	None posted
Jun 8, 1976	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 26, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17584
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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