Maxaquin

NDA 20013, held by Pharmacia. Lomefloxacin Hydrochloride.

As of Nov 13, 2026, NDA 20013 (Maxaquin), held by Pharmacia, was first approved by FDA on Feb 21, 1992, with 12 approved supplements and 0 published complete response letters.

First approved: Feb 21, 1992
Review: Standard
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Oct 9, 1996	Supplement 7Efficacy (new indication or use) · Standard review	Approved	None posted
Feb 21, 1992	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
MaxaquinEQ 400MG BASE · tablet;oral	Lomefloxacin Hydrochloride	Discontinued

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 16, 2005	Supplement 15Labeling · Standard review	Approved	Letter Label
Mar 6, 2004	Supplement 14Labeling · Standard review	Approved	Label Letter
Oct 24, 2001	Supplement 8Labeling · Standard review	Approved	Label
May 6, 1999	Supplement 11Labeling · Standard review	Approved	None posted
May 6, 1999	Supplement 12Labeling · Standard review	Approved	None posted
May 6, 1999	Supplement 13Labeling · Standard review	Approved	None posted
Feb 20, 1997	Supplement 9Labeling · Standard review	Approved	None posted
Oct 9, 1996	Supplement 7Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 27, 1996	Supplement 6Labeling · Standard review	Approved	None posted
Sep 11, 1996	Supplement 10Labeling · Standard review	Approved	None posted
Sep 20, 1993	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 21, 1993	Supplement 2Labeling · Standard review	Approved	None posted
Feb 21, 1992	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 20013
Drugs@FDA: Overview at FDA
Company: Pharmacia

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