← FDA DRUG APPROVALS

FDA NDA · NDA020634

LEVAQUIN

Sponsor: JANSSEN PHARMS

APPLICATION
NDA020634
TYPE
NDA
ORIGINAL APPROVAL
1996-12-20
LATEST ACTION
2020-06-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LEVAQUIN · ReferenceDiscontinued
LEVOFLOXACIN 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
LEVAQUIN · ReferenceDiscontinued
LEVOFLOXACIN 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
LEVAQUIN · ReferenceDiscontinued
LEVOFLOXACIN 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2020-06-22Labeling · Supplement 73 · standard — Letter ↗AP
2019-06-28Labeling · Supplement 71 · standard — Letter ↗AP
2019-05-03Labeling · Supplement 72 · standard — Letter ↗AP
2018-10-18Labeling · Supplement 70 · standard — Label ↗AP
2018-07-02Labeling · Supplement 69 · standard — Label ↗AP
2017-02-08Labeling · Supplement 68 · standard — Letter ↗AP
2016-07-26Labeling · Supplement 67 · standard — Label ↗AP
2014-05-23Labeling · Supplement 66 · standard — Label ↗AP
2013-08-14Labeling · Supplement 65 · 901 required — Label ↗AP
2012-04-27Efficacy · Supplement 61 · priority — Review ↗AP
2011-10-11REMS · Supplement 64 — Review ↗AP
2011-10-11Labeling · Supplement 62 · unknown — Review ↗AP
2011-06-09Labeling · Supplement 59 · unknown — Letter ↗AP
2011-02-25Labeling · Supplement 58 · 901 required — Label ↗AP
2009-04-27Labeling · Supplement 53 · standard — Letter ↗AP
2009-03-12Labeling · Supplement 54 · standard — Letter ↗AP
2008-10-03Labeling · Supplement 52 · standard — Letter ↗AP
2008-05-05Efficacy · Supplement 47 · unknown — Summary Review ↗AP
2008-04-16Labeling · Supplement 51 · standard — Label ↗AP
2007-12-13Labeling · Supplement 50 · standard — Label ↗AP
2007-11-16Labeling · Supplement 49 · standard — Label ↗AP
2007-11-15Labeling · Supplement 48 · standard — Letter ↗AP
2007-09-14Efficacy · Supplement 41 · unknown — Label ↗AP
2007-09-11Efficacy · Supplement 43 · priority — Pediatric Written Request ↗AP
2007-06-19Labeling · Supplement 45 · standard — Label ↗AP
2007-05-31Labeling · Supplement 42 · standard — Label ↗AP
2007-05-10Labeling · Supplement 44 · standard — Letter ↗AP
2006-06-23Labeling · Supplement 40 · standard — Letter ↗AP
2006-01-20Labeling · Supplement 39 · standard — Label ↗AP
2005-08-04Efficacy · Supplement 37 · unknown — Letter ↗AP
2004-11-24Efficacy · Supplement 35 · priority — Letter ↗AP
2004-11-04Labeling · Supplement 36 · standard — Letter ↗AP
2004-09-14Labeling · Supplement 33 · standard — Review ↗AP
2004-09-14Labeling · Supplement 34 · standard — Review ↗AP
2004-07-14Efficacy · Supplement 30 · priority — Label ↗AP
2004-03-05Labeling · Supplement 29 · standard — Letter ↗AP
2003-10-23Efficacy · Supplement 28 · standard — Review ↗AP
2003-05-23Efficacy · Supplement 27 · standard — Review ↗AP
2002-10-30Efficacy · Supplement 25 · priority — Letter ↗AP
2002-06-12Manufacturing (CMC) · Supplement 26 · standardAP
VIEW ON DRUGS@FDA ↗

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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.

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