MOXIFLOXACIN HYDROCHLORIDE | N021085 | BAYER HEALTHCARE PHARMACEUTICALS INC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 1 | Active | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 60 | 2026-07-30 → 2027-02 | |
| Phase 3 | Active | University of California, San Francisco | 60 | 2024-07-01 → 2027-02-28 | |
| N/A | Active | Turku University Hospital | 552 | 2017-04-03 → 2029-04-01 | |
| Phase 1 | Active | Boehringer Ingelheim | 45 | 2026-04-22 → 2026-08-21 | |
| Phase 2 | Not Yet Recruiting | National Institute of Allergy and Infectious Diseases (NIAID) | 900 | 2026-10-30 → 2029-10-22 | |
| Phase 2/3 | Not Yet Recruiting | Jason Ahee, M.D. | 60,000 | 2026-06-01 → 2031-10 | |
| Phase 1 | Not Yet Recruiting | Boehringer Ingelheim | 56 | 2026-08-17 → 2026-12-30 | |
| N/A | Not Yet Recruiting | The First Affiliated Hospital of Shihezi University | 350 | 2026-09-01 → 2027-12 | |
| Phase 3 | Recruiting | UMC Utrecht | 20,000 | 2016-04-11 → 2028-02 | |
| Phase 2/3 | Recruiting | The University of Queensland | 300 | 2020-03-02 → 2030-06-30 |
Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.
17 active API suppliers hold Drug Master Files for this ingredient.
Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.
| Date | Submission | Document |
|---|---|---|
| Jul 14, 2025 | SUPPL -69 | View Letter (PDF) |
| May 7, 2020 | SUPPL -66 | View Letter (PDF) |
| May 6, 2019 | SUPPL -65 | View Letter (PDF) |
| Oct 23, 2018 | SUPPL -64 | View Letter (PDF) |
| Sep 30, 2016 | SUPPL -62 | View Letter (PDF) |
| Sep 30, 2016 | SUPPL -61 | View Letter (PDF) |
| Jul 26, 2016 | SUPPL -63 | View Letter (PDF) |
| May 13, 2015 | SUPPL -60 | View Letter (PDF) |
| Nov 24, 2014 | SUPPL -59 | View Letter (PDF) |
| Aug 16, 2013 | SUPPL -57 | View Letter (PDF) |
| Dec 26, 2012 | SUPPL -56 | View Letter (PDF) |
| Aug 28, 2012 | SUPPL -55 | View Letter (PDF) |
| Oct 20, 2011 | SUPPL -53 | View Letter (PDF) |
| Oct 20, 2011 | SUPPL -50 | View Letter (PDF) |
| Aug 8, 2011 | SUPPL -52 | View Letter (PDF) |
| Mar 2, 2011 | SUPPL -47 | View Letter (PDF) |
| Nov 2, 2010 | SUPPL -44 | View Letter (PDF) |
| Apr 9, 2010 | SUPPL -46 | View Letter (PDF) |
| Jan 25, 2010 | SUPPL -45 | View Letter (PDF) |
| Jun 29, 2009 | SUPPL -41 | View Letter (PDF) |
| May 5, 2009 | SUPPL -42 | View Letter (PDF) |
| Dec 31, 2008 | SUPPL -39 | View Letter (PDF) |
| Oct 7, 2008 | SUPPL -40 | View Letter (PDF) |
| Feb 20, 2008 | SUPPL -38 | View Letter (PDF) |
| Jun 4, 2007 | SUPPL -36 | View Letter (PDF) |
| Nov 30, 2005 | SUPPL -27 | View Letter (PDF) |
| Nov 30, 2005 | SUPPL -29 | View Letter (PDF) |
| Jun 14, 2005 | SUPPL -26 | View Letter (PDF) |
| Jul 30, 2004 | SUPPL -24 | View Letter (PDF) |
| May 26, 2004 | SUPPL -22 | View Letter (PDF) |
| Mar 10, 2004 | SUPPL -23 | View Letter (PDF) |
| Oct 6, 2003 | SUPPL -19 | View Letter (PDF) |
| Mar 10, 2003 | SUPPL -14 | View Letter (PDF) |
| Mar 10, 2003 | SUPPL -15 | View Letter (PDF) |
| Mar 10, 2003 | SUPPL -17 | View Letter (PDF) |
| Jun 12, 2002 | SUPPL -6 | View Letter (PDF) |
| Jun 12, 2002 | SUPPL -7 | View Letter (PDF) |
| May 16, 2002 | SUPPL -12 | View Letter (PDF) |
| Apr 27, 2001 | SUPPL -10 | View Letter (PDF) |
| Dec 10, 1999 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.