← FDA DRUG APPROVALS

FDA NDA · NDA021721

LEVAQUIN

Sponsor: JANSSEN PHARMS

APPLICATION
NDA021721
TYPE
NDA
ORIGINAL APPROVAL
2004-10-21
LATEST ACTION
2017-02-08
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

LEVAQUIN · ReferenceDiscontinued
LEVOFLOXACIN 250MG/10ML · SOLUTION · ORAL

Approval history

2017-02-08Labeling · Supplement 35 · standard — Letter ↗AP
2016-07-26Labeling · Supplement 34 · standard — Label ↗AP
2014-05-23Labeling · Supplement 33 · standard — Label ↗AP
2013-08-14Labeling · Supplement 32 · 901 required — Letter ↗AP
2012-04-27Efficacy · Supplement 28 · priority — Label ↗AP
2011-10-11Labeling · Supplement 29 · unknown — Label ↗AP
2011-10-11REMS · Supplement 31 — Review ↗AP
2011-06-09Labeling · Supplement 26 · standard — Label ↗AP
2011-02-25Labeling · Supplement 25 · 901 required — Label ↗AP
2009-04-27Labeling · Supplement 21 · standard — Letter ↗AP
2009-03-12Labeling · Supplement 22 · standard — Letter ↗AP
2008-10-03Labeling · Supplement 20 · standard — Letter ↗AP
2008-05-05Efficacy · Supplement 15 · unknown — Summary Review ↗AP
2008-04-16Labeling · Supplement 19 · standard — Label ↗AP
2007-12-13Labeling · Supplement 18 · standard — Letter ↗AP
2007-11-16Labeling · Supplement 17 · standard — Letter ↗AP
2007-11-15Labeling · Supplement 16 · standard — Label ↗AP
2007-09-14Efficacy · Supplement 9 · unknown — Label ↗AP
2007-09-11Efficacy · Supplement 11 · priority — Label ↗AP
2007-06-19Labeling · Supplement 13 · standard — Label ↗AP
2007-05-31Labeling · Supplement 10 · standard — Letter ↗AP
2007-05-10Labeling · Supplement 12 · standard — Letter ↗AP
2006-06-23Labeling · Supplement 7 · standard — Letter ↗AP
2006-01-20Labeling · Supplement 6 · standard — Label ↗AP
2005-08-04Efficacy · Supplement 2 · unknown — Label ↗AP
2004-11-24Efficacy · Supplement 3 · priority — Label ↗AP
2004-10-21Type 3 - New Dosage Form · Original · standard — Medication Guide ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →