Lidocaine Hydrochloride 0.1% And Dextrose 5% In Plastic Container, Lidocaine Hydrochloride 0.2% And Dextrose 5% In Plastic Container, Lidocaine Hydrochloride 0.4% And Dextrose 5% In Plastic Container

NDA 18461, held by Baxter Hlthcare. Lidocaine Hydrochloride.

As of Nov 14, 2026, NDA 18461 (Lidocaine Hydrochloride 0.1% And Dextrose 5% In Plastic Container, Lidocaine Hydrochloride 0.2% And Dextrose 5% In Plastic Container, Lidocaine Hydrochloride 0.4% And Dextrose 5% In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Apr 22, 1981, with 45 approved supplements and 0 published complete response letters.

First approved: Apr 22, 1981
Review: Standard
Supplements approved: 45
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lidocaine hydrochloride administered intravenously is specifically indicated in the acute management of ventricular arrhythmias occurring during cardiac manipulations, such as cardiac surgery and life-threatening arrhythmias which are ventricular in origin, such as occur during acute myocardial infarction.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 46 submissions below

Date	Submission	Status	Documents
Apr 22, 1981	Original applicationNew dosage form · Standard review	Approved	None posted

Products

4 strengths and forms


Lidocaine Hydrochloride 0.1% And Dextrose 5% In Plastic Container100MG/100ML · injectable;injection	Lidocaine Hydrochloride	Discontinued
Lidocaine Hydrochloride 0.2% And Dextrose 5% In Plastic Container200MG/100ML · injectable;injection	Lidocaine Hydrochloride	Rx
Lidocaine Hydrochloride 0.4% And Dextrose 5% In Plastic Container400MG/100ML · injectable;injection	Lidocaine Hydrochloride	Rx
Lidocaine Hydrochloride 0.8% And Dextrose 5% In Plastic Container800MG/100ML · injectable;injection	Lidocaine Hydrochloride	Rx

All 46 submissions, including labeling and manufacturing supplements


Feb 7, 2017	Supplement 58Labeling · Standard review	Approved	Letter Label
Apr 7, 2015	Supplement 57Manufacturing · Standard review	Approved	None posted
Mar 5, 2012	Supplement 56Labeling	Approved	Letter Label
Feb 27, 2012	Supplement 55Labeling · Standard review	Approved	Letter
Dec 11, 2003	Supplement 52Labeling · Standard review	Approved	Letter
Jan 23, 2002	Supplement 50Labeling · Standard review	Approved	Review Label Letter
Nov 23, 1999	Supplement 48Manufacturing · Standard review	Approved	None posted
Jun 3, 1999	Supplement 47Manufacturing · Standard review	Approved	None posted
Sep 18, 1998	Supplement 46Labeling · Standard review	Approved	None posted
Sep 29, 1994	Supplement 45Manufacturing · Standard review	Approved	None posted
Mar 16, 1994	Supplement 44Manufacturing · Standard review	Approved	None posted
Jan 8, 1993	Supplement 43Labeling · Standard review	Approved	None posted
Apr 29, 1991	Supplement 40Manufacturing · Standard review	Approved	None posted
Apr 3, 1991	Supplement 41Manufacturing · Standard review	Approved	None posted
Mar 26, 1991	Supplement 38Manufacturing · Standard review	Approved	None posted
Feb 15, 1991	Supplement 37Manufacturing · Standard review	Approved	None posted
May 24, 1990	Supplement 39Manufacturing · Standard review	Approved	None posted
Jul 26, 1989	Supplement 36Manufacturing · Standard review	Approved	None posted
Jan 12, 1989	Supplement 35Manufacturing · Standard review	Approved	None posted
Jul 25, 1987	Supplement 33Manufacturing · Standard review	Approved	None posted
May 28, 1987	Supplement 32Manufacturing · Standard review	Approved	None posted
Sep 4, 1986	Supplement 23Labeling	Approved	None posted
Jun 19, 1986	Supplement 31Labeling	Approved	None posted
Feb 27, 1986	Supplement 28Manufacturing · Standard review	Approved	None posted
Sep 13, 1985	Supplement 26Labeling	Approved	None posted
Jun 13, 1985	Supplement 25Manufacturing · Standard review	Approved	None posted
Jun 11, 1985	Supplement 20Manufacturing · Standard review	Approved	None posted
Apr 15, 1985	Supplement 27Manufacturing · Standard review	Approved	None posted
Jan 24, 1985	Supplement 17Manufacturing · Standard review	Approved	None posted
Oct 23, 1984	Supplement 24Manufacturing · Standard review	Approved	None posted
Apr 30, 1984	Supplement 21Labeling	Approved	None posted
Mar 16, 1984	Supplement 14Manufacturing · Standard review	Approved	None posted
Feb 28, 1984	Supplement 22Manufacturing · Standard review	Approved	None posted
Mar 14, 1983	Supplement 18Manufacturing · Standard review	Approved	None posted
Jun 3, 1982	Supplement 7Manufacturing · Standard review	Approved	None posted
May 25, 1982	Supplement 12Labeling	Approved	None posted
Apr 16, 1982	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 22, 1982	Supplement 9Labeling	Approved	None posted
Feb 22, 1982	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 21, 1981	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 20, 1981	Supplement 11Manufacturing · Standard review	Approved	None posted
Oct 1, 1981	Supplement 6Labeling	Approved	None posted
Oct 1, 1981	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 27, 1981	Supplement 2Labeling	Approved	None posted
Jul 22, 1981	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 22, 1981	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18461
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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