Lidocaine Hydrochloride Preservative Free

NDA 17702, held by Intl Medication. Lidocaine Hydrochloride.

As of Nov 14, 2026, NDA 17702 (Lidocaine Hydrochloride Preservative Free), held by Intl Medication, was first approved by FDA on Dec 20, 1976, with 14 approved supplements and 0 published complete response letters.

First approved: Dec 20, 1976
Review: Standard
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Dec 20, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Lidocaine Hydrochloride Preservative Free20% · injectable;injection	Lidocaine Hydrochloride	Discontinued
Lidocaine Hydrochloride Preservative Free4% · injectable;injection	Lidocaine Hydrochloride	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Oct 18, 1995	Supplement 25Manufacturing · Standard review	Approved	None posted
Oct 6, 1993	Supplement 24Labeling · Standard review	Approved	None posted
May 17, 1993	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 17, 1993	Supplement 19Manufacturing · Standard review	Approved	None posted
Dec 14, 1992	Supplement 18Manufacturing · Standard review	Approved	None posted
Dec 11, 1992	Supplement 21Manufacturing · Standard review	Approved	None posted
Nov 6, 1992	Supplement 20Manufacturing · Standard review	Approved	None posted
Jun 12, 1992	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 11, 1992	Supplement 17Manufacturing · Standard review	Approved	None posted
Jun 26, 1986	Supplement 10Labeling	Approved	None posted
Jul 11, 1978	Supplement 4Labeling	Approved	None posted
Jul 11, 1978	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 24, 1977	Supplement 2Labeling	Approved	None posted
Aug 24, 1977	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 20, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17702
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