NDA 21277, held by Bayer Hlthcare. Moxifloxacin Hydrochloride.
As of Nov 14, 2026, NDA 21277 (Avelox In Sodium Chloride 0.8% In Plastic Container), held by Bayer Hlthcare, was first approved by FDA on Nov 30, 2001, with 39 approved supplements and 0 published complete response letters.
| Sep 27, 2016 | Supplement 57Efficacy (new indication or use) · Priority review | Approved | |
| May 8, 2015 | Supplement 56Efficacy (new indication or use) · Standard review | Approved | |
| Nov 22, 2005 | Supplement 24Efficacy (new indication or use) | Approved | |
| Jun 13, 2005 | Supplement 22Efficacy (new indication or use) · Standard review | Approved | |
| May 18, 2004 | Supplement 17Efficacy (new indication or use) · Priority review | Approved | |
| Feb 28, 2003 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Nov 30, 2001 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Avelox In Sodium Chloride 0.8% In Plastic Container400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intravenous | Moxifloxacin Hydrochloride | DiscontinuedReference drug |
| Jul 11, 2025 | Supplement 65Labeling · Standard review | Approved | |
| May 6, 2020 | Supplement 62Labeling · Standard review | Approved | |
| May 3, 2019 | Supplement 61Labeling · Standard review | Approved | |
| Oct 18, 2018 | Supplement 60Labeling · Standard review | Approved | |
| Sep 27, 2016 | Supplement 58Labeling · Standard review | Approved | |
| Sep 27, 2016 | Supplement 57Efficacy (new indication or use) · Priority review | Approved | |
| Jul 26, 2016 | Supplement 59Labeling · Standard review | Approved | |
| May 8, 2015 | Supplement 56Efficacy (new indication or use) · Standard review | Approved | |
| Nov 20, 2014 | Supplement 55Labeling · Standard review | Approved | |
| Aug 14, 2013 | Supplement 54Labeling | Approved | |
| Dec 18, 2012 | Supplement 53Labeling · Standard review | Approved | |
| Aug 24, 2012 | Supplement 52Labeling · Standard review | Approved | |
| Oct 18, 2011 | Supplement 50Labeling | Approved | |
| Oct 18, 2011 | Supplement 46Labeling | Approved | |
| Aug 3, 2011 | Supplement 49REMS | Approved | |
| Feb 25, 2011 | Supplement 41Labeling | Approved | |
| Oct 25, 2010 | Supplement 38Labeling · Standard review | Approved | |
| Mar 2, 2010 | Supplement 40Labeling | Approved | |
| Nov 24, 2009 | Supplement 39Labeling | Approved | |
| Jun 24, 2009 | Supplement 35Labeling · Standard review | Approved | |
| Apr 27, 2009 | Supplement 36Labeling · Standard review | Approved | |
| Dec 29, 2008 | Supplement 33Labeling · Standard review | Approved | |
| Oct 3, 2008 | Supplement 34Labeling · Standard review | Approved | |
| Feb 15, 2008 | Supplement 31Labeling · Standard review | Approved | |
| May 31, 2007 | Supplement 30Labeling · Standard review | Approved | |
| Nov 22, 2005 | Supplement 25Labeling · Standard review | Approved | |
| Nov 22, 2005 | Supplement 24Efficacy (new indication or use) | Approved | |
| Jun 13, 2005 | Supplement 22Efficacy (new indication or use) · Standard review | Approved | |
| Jul 28, 2004 | Supplement 19Labeling · Standard review | Approved | |
| May 18, 2004 | Supplement 17Efficacy (new indication or use) · Priority review | Approved | |
| Mar 6, 2004 | Supplement 18Labeling · Standard review | Approved | |
| Oct 6, 2003 | Supplement 11Labeling · Standard review | Approved | |
| Feb 28, 2003 | Supplement 9Labeling · Standard review | Approved | |
| Feb 28, 2003 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Feb 28, 2003 | Supplement 6Labeling · Standard review | Approved | |
| Dec 10, 2002 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jun 12, 2002 | Supplement 2Labeling · Standard review | Approved | |
| May 22, 2002 | Supplement 1Labeling · Standard review | Approved | |
| May 16, 2002 | Supplement 3Labeling · Standard review | Approved | |
| Nov 30, 2001 | Original applicationNew dosage form · 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
