MOXIFLOXACIN HYDROCHLORIDE | N205572 | FRESENIUS KABI USA LLC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 1 | Active | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 60 | 2026-07-30 → 2027-02 | |
| Phase 2/3 | Active | Centers for Disease Control and Prevention | 288 | 2023-11-21 → 2027-12-31 | |
| N/A | Active | Turku University Hospital | 552 | 2017-04-03 → 2029-04-01 | |
| N/A | Active | Seoul National University Bundang Hospital | 141 | 2021-02-01 → 2027-09-28 | |
| Phase 3 | Active | University of California, San Francisco | 60 | 2024-07-01 → 2027-02-28 | |
| N/A | Not Yet Recruiting | Nishtar Medical University | 60 | 2026-10-01 → 2027-02-15 | |
| N/A | Not Yet Recruiting | The First Affiliated Hospital of Shihezi University | 350 | 2026-09-01 → 2027-12 | |
| Phase 2/3 | Not Yet Recruiting | Jason Ahee, M.D. | 60,000 | 2027-06-01 → 2031-10 | |
| Phase 2 | Not Yet Recruiting | National Institute of Allergy and Infectious Diseases (NIAID) | 900 | 2026-10-30 → 2029-10-22 | |
| N/A | Not Yet Recruiting | Assiut University | 93 | 2026-09-26 → 2028-02-25 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
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 |
|---|---|---|
| Mar 30, 2020 | SUPPL -5 | View Letter (PDF) |
| May 7, 2019 | SUPPL -6 | View Letter (PDF) |
| Oct 23, 2018 | SUPPL -4 | View Letter (PDF) |
| Jul 26, 2016 | SUPPL -2 | View Letter (PDF) |
| Apr 8, 2015 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.