Levaquin

NDA 20634, held by Janssen Pharms. Levofloxacin.

As of Nov 14, 2026, NDA 20634 (Levaquin), held by Janssen Pharms, was first approved by FDA on Dec 20, 1996, with 64 approved supplements and 0 published complete response letters.

First approved: Dec 20, 1996
Supplements approved: 64
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 65 submissions below


Apr 27, 2012	Supplement 61Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
May 5, 2008	Supplement 47Efficacy (new indication or use)	Approved	Summary Review Letter
Sep 14, 2007	Supplement 41Efficacy (new indication or use)	Approved	Letter Label
Sep 11, 2007	Supplement 43Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Written Request Pediatric Amendment 1
Aug 4, 2005	Supplement 37Efficacy (new indication or use)	Approved	Letter Label
Nov 24, 2004	Supplement 35Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jul 14, 2004	Supplement 30Efficacy (new indication or use) · Priority review	Approved	Label
Oct 23, 2003	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Review Letter
May 23, 2003	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Oct 30, 2002	Supplement 25Efficacy (new indication or use) · Priority review	Approved	Letter
Sep 8, 2000	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 2, 2000	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Review Letter
Dec 17, 1998	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Label Other Review Letter
Dec 20, 1996	Original applicationNew dosage form	Approved	Review

Products

3 strengths and forms


Levaquin250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Levofloxacin	DiscontinuedReference drug
Levaquin500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Levofloxacin	DiscontinuedReference drug
Levaquin750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Levofloxacin	DiscontinuedReference drug

All 65 submissions, including labeling and manufacturing supplements


Jun 22, 2020	Supplement 73Labeling · Standard review	Approved	Label Medication Guide Letter
Jun 28, 2019	Supplement 71Labeling · Standard review	Approved	Label Medication Guide Letter
May 3, 2019	Supplement 72Labeling · Standard review	Approved	Label Letter
Oct 18, 2018	Supplement 70Labeling · Standard review	Approved	Letter Label Medication Guide
Jul 2, 2018	Supplement 69Labeling · Standard review	Approved	Letter Label Medication Guide
Feb 8, 2017	Supplement 68Labeling · Standard review	Approved	Label Letter
Jul 26, 2016	Supplement 67Labeling · Standard review	Approved	Label Letter
May 23, 2014	Supplement 66Labeling · Standard review	Approved	Letter Label
Aug 14, 2013	Supplement 65Labeling	Approved	Letter Label
Apr 27, 2012	Supplement 61Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Oct 11, 2011	Supplement 64REMS	Approved	Review Letter Label
Oct 11, 2011	Supplement 62Labeling	Approved	Review Letter Label
Jun 9, 2011	Supplement 59Labeling	Approved	Letter Label
Feb 25, 2011	Supplement 58Labeling	Approved	Label Letter
Apr 27, 2009	Supplement 53Labeling · Standard review	Approved	Label Letter
Mar 12, 2009	Supplement 54Labeling · Standard review	Approved	Letter
Oct 3, 2008	Supplement 52Labeling · Standard review	Approved	Label Letter
May 5, 2008	Supplement 47Efficacy (new indication or use)	Approved	Summary Review Letter
Apr 16, 2008	Supplement 51Labeling · Standard review	Approved	Label Letter
Dec 13, 2007	Supplement 50Labeling · Standard review	Approved	Letter Label
Nov 16, 2007	Supplement 49Labeling · Standard review	Approved	Letter Label
Nov 15, 2007	Supplement 48Labeling · Standard review	Approved	Letter Label
Sep 14, 2007	Supplement 41Efficacy (new indication or use)	Approved	Letter Label
Sep 11, 2007	Supplement 43Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Written Request Pediatric Amendment 1
Jun 19, 2007	Supplement 45Labeling · Standard review	Approved	Letter Label
May 31, 2007	Supplement 42Labeling · Standard review	Approved	Letter Label
May 10, 2007	Supplement 44Labeling · Standard review	Approved	Letter Label
Jun 23, 2006	Supplement 40Labeling · Standard review	Approved	Letter Label
Jan 20, 2006	Supplement 39Labeling · Standard review	Approved	Label
Aug 4, 2005	Supplement 37Efficacy (new indication or use)	Approved	Letter Label
Nov 24, 2004	Supplement 35Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 4, 2004	Supplement 36Labeling · Standard review	Approved	Letter Label
Sep 14, 2004	Supplement 33Labeling · Standard review	Approved	Review Letter Label
Sep 14, 2004	Supplement 34Labeling · Standard review	Approved	Review Letter Label
Jul 14, 2004	Supplement 30Efficacy (new indication or use) · Priority review	Approved	Label
Mar 5, 2004	Supplement 29Labeling · Standard review	Approved	Label Letter
Oct 23, 2003	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Review Letter
May 23, 2003	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Oct 30, 2002	Supplement 25Efficacy (new indication or use) · Priority review	Approved	Letter
Jun 12, 2002	Supplement 26Manufacturing · Standard review	Approved	None posted
Apr 30, 2002	Supplement 24Manufacturing · Standard review	Approved	None posted
Jan 11, 2002	Supplement 23Manufacturing · Standard review	Approved	None posted
Dec 18, 2001	Supplement 15Labeling · Standard review	Approved	Review Letter Label
Dec 18, 2001	Supplement 21Labeling · Standard review	Approved	Review Letter Label
Dec 18, 2001	Supplement 22Labeling · Standard review	Approved	Review Letter Label
Jun 8, 2001	Supplement 20Manufacturing · Standard review	Approved	None posted
Feb 13, 2001	Supplement 19Manufacturing · Standard review	Approved	None posted
Jan 4, 2001	Supplement 18Manufacturing · Standard review	Approved	None posted
Dec 13, 2000	Supplement 16Manufacturing · Standard review	Approved	None posted
Sep 15, 2000	Supplement 17Manufacturing · Standard review	Approved	None posted
Sep 8, 2000	Supplement 12Manufacturing · Standard review	Approved	Label Letter
Sep 8, 2000	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 28, 2000	Supplement 14Manufacturing · Standard review	Approved	None posted
Feb 11, 2000	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 2, 2000	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Review Letter
Feb 2, 2000	Supplement 9Labeling · Standard review	Approved	Review Letter
Sep 29, 1999	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 29, 1999	Supplement 5Labeling · Standard review	Approved	None posted
Jul 29, 1999	Supplement 6Labeling · Standard review	Approved	None posted
Jul 29, 1999	Supplement 7Labeling · Standard review	Approved	None posted
Dec 17, 1998	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Label Other Review Letter
May 11, 1998	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 24, 1998	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 30, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 20, 1996	Original applicationNew dosage form	Approved	Review

Show all 65

Identifiers

Application: NDA 20634
Drugs@FDA: Overview at FDA
Company: Janssen Pharmaceuticals, Inc.

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