Lidopen

NDA 17549, held by Meridian Medcl Techn. Lidocaine Hydrochloride.

As of Nov 13, 2026, NDA 17549 (Lidopen), held by Meridian Medcl Techn, was first approved by FDA on Mar 28, 1975, with 16 approved supplements and 0 published complete response letters.

First approved: Mar 28, 1975
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below


Oct 18, 1976	Supplement 3Efficacy (new indication or use)	Approved	None posted
Mar 28, 1975	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lidopen10% · injectable;injection	Lidocaine Hydrochloride	Discontinued

All 17 submissions, including labeling and manufacturing supplements


Oct 31, 2002	Supplement 20Manufacturing · Standard review	Approved	None posted
Oct 20, 2000	Supplement 19Manufacturing · Standard review	Approved	None posted
Dec 8, 1999	Supplement 18Manufacturing · Standard review	Approved	None posted
Jul 21, 1998	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 18, 1997	Supplement 16Manufacturing · Standard review	Approved	None posted
Jan 9, 1997	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 6, 1996	Supplement 14Manufacturing · Standard review	Approved	None posted
May 10, 1993	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 23, 1988	Supplement 12Manufacturing · Standard review	Approved	None posted
Dec 10, 1986	Supplement 11Labeling	Approved	None posted
Apr 16, 1984	Supplement 8Labeling	Approved	None posted
Jan 11, 1978	Supplement 7Labeling	Approved	None posted
Mar 17, 1977	Supplement 4Labeling	Approved	None posted
Oct 18, 1976	Supplement 3Efficacy (new indication or use)	Approved	None posted
Dec 4, 1975	Supplement 2Manufacturing · Standard review	Approved	None posted
Sep 24, 1975	Supplement 1Labeling	Approved	None posted
Mar 28, 1975	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17549
Drugs@FDA: Overview at FDA
Company: Meridian Medcl Techn

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