Lidocaine Hydrochloride

NDA 17701, held by Intl Medication. Lidocaine Hydrochloride.

As of Nov 13, 2026, NDA 17701 (Lidocaine Hydrochloride), held by Intl Medication, was first approved by FDA on Dec 3, 1976, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 3, 1976
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Dec 3, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Lidocaine Hydrochloride2% · injectable;injection	Lidocaine Hydrochloride	Discontinued
Lidocaine Hydrochloride1% · injectable;injection	Lidocaine Hydrochloride	Discontinued

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 30, 1986	Supplement 9Labeling	Approved	None posted
Jan 15, 1986	Supplement 8Labeling	Approved	None posted
Aug 23, 1985	Supplement 6Labeling	Approved	None posted
Jul 12, 1979	Supplement 1Labeling	Approved	None posted
Dec 3, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17701
Drugs@FDA: Overview at FDA
Company: International Medication Systems

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