NDA 21085, held by Bayer Hlthcare. Moxifloxacin Hydrochloride.
As of Nov 14, 2026, NDA 21085 (Avelox), held by Bayer Hlthcare, was first approved by FDA on Dec 10, 1999, with 47 approved supplements and 0 published complete response letters.
| Sep 27, 2016 | Supplement 61Efficacy (new indication or use) · Priority review | Approved | |
| May 8, 2015 | Supplement 60Efficacy (new indication or use) · Standard review | Approved | |
| Nov 22, 2005 | Supplement 27Efficacy (new indication or use) | Approved | |
| Jun 13, 2005 | Supplement 26Efficacy (new indication or use) | Approved | |
| May 18, 2004 | Supplement 22Efficacy (new indication or use) · Priority review | Approved | |
| Feb 28, 2003 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Dec 10, 1999 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| AveloxEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Moxifloxacin Hydrochloride | DiscontinuedReference drug |
| Jul 11, 2025 | Supplement 69Labeling · Standard review | Approved | |
| May 6, 2020 | Supplement 66Labeling · Standard review | Approved | |
| May 3, 2019 | Supplement 65Labeling · Standard review | Approved | |
| Oct 18, 2018 | Supplement 64Labeling · Standard review | Approved | |
| Sep 27, 2016 | Supplement 61Efficacy (new indication or use) · Priority review | Approved | |
| Sep 27, 2016 | Supplement 62Labeling · Standard review | Approved | |
| Jul 26, 2016 | Supplement 63Labeling · Standard review | Approved | |
| May 8, 2015 | Supplement 60Efficacy (new indication or use) · Standard review | Approved | |
| Nov 20, 2014 | Supplement 59Labeling · Standard review | Approved | |
| Nov 19, 2014 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Aug 14, 2013 | Supplement 57Labeling | Approved | |
| Dec 18, 2012 | Supplement 56Labeling · Standard review | Approved | |
| Aug 24, 2012 | Supplement 55Labeling · Standard review | Approved | |
| Oct 18, 2011 | Supplement 50Labeling · Standard review | Approved | |
| Oct 18, 2011 | Supplement 53Labeling | Approved | |
| Aug 3, 2011 | Supplement 52REMS | Approved | |
| Feb 25, 2011 | Supplement 47Labeling | Approved | |
| Oct 25, 2010 | Supplement 44Labeling · Standard review | Approved | |
| Mar 2, 2010 | Supplement 46Labeling | Approved | |
| Nov 24, 2009 | Supplement 45Labeling | Approved | |
| Jun 24, 2009 | Supplement 41Labeling · Standard review | Approved | |
| Apr 27, 2009 | Supplement 42Labeling · Standard review | Approved | |
| Dec 29, 2008 | Supplement 39Labeling · Standard review | Approved | |
| Oct 3, 2008 | Supplement 40Labeling · Standard review | Approved | |
| Feb 15, 2008 | Supplement 38Labeling · Standard review | Approved | |
| May 31, 2007 | Supplement 36Labeling · Standard review | Approved | |
| Nov 22, 2005 | Supplement 29Labeling · Standard review | Approved | |
| Nov 22, 2005 | Supplement 27Efficacy (new indication or use) | Approved | |
| Jun 13, 2005 | Supplement 26Efficacy (new indication or use) | Approved | |
| Dec 14, 2004 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Jul 28, 2004 | Supplement 24Labeling · Standard review | Approved | |
| May 18, 2004 | Supplement 22Efficacy (new indication or use) · Priority review | Approved | |
| Mar 6, 2004 | Supplement 23Labeling · Standard review | Approved | |
| Oct 6, 2003 | Supplement 19Labeling · Standard review | Approved | |
| Feb 28, 2003 | Supplement 17Labeling · Standard review | Approved | |
| Feb 28, 2003 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Feb 28, 2003 | Supplement 14Labeling · Standard review | Approved | |
| Dec 10, 2002 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jun 12, 2002 | Supplement 7Labeling · Standard review | Approved | |
| Jun 12, 2002 | Supplement 6Labeling · Standard review | Approved | |
| May 16, 2002 | Supplement 12Labeling · Standard review | Approved | |
| May 17, 2001 | Supplement 5Labeling · Standard review | Approved | None posted |
| May 17, 2001 | Supplement 4Labeling · Standard review | Approved | None posted |
| Apr 27, 2001 | Supplement 10Labeling · Standard review | Approved | |
| Feb 2, 2001 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| May 4, 2000 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 21, 2000 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Dec 10, 1999 | Original applicationNew molecular entity · Standard review | Approved |
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
