AMOXICILLIN | N050761 | US ANTIBIOTICS LLC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 3 | Active | National Cancer Center, Korea | 470 | 2003-06 → 2030-06 | |
| Phase 3 | Recruiting | University Medical Centre Ljubljana | 200 | 2019-06-01 → 2027-12-31 | |
| Phase 2/3 | Recruiting | St. Justine's Hospital | 1,370 | 2017-06-11 → 2027-06-01 | |
| N/A | Recruiting | Seoul National University Bundang Hospital | 600 | 2014-08 → 2027-12 | |
| Phase 4 | Recruiting | Woman's | 34 | 2019-08-28 → 2021-07-01 | |
| Phase 3 | Recruiting | UMC Utrecht | 20,000 | 2016-04-11 → 2028-02 | |
| Phase 4 | Completed | Shanghai Jiao Tong University School of Medicine | 216 | 2018-05-25 → 2019-06-10 | |
| Phase 4 | Completed | National Institute of Mental Health (NIMH) | 30 | 1997-07 → 2001-06 | |
| Phase 4 | Completed | University of Catania | 100 | 2004-01 → 2006-09 | |
| Phase 2 | Completed | MerLion Pharmaceuticals GmbH | 30 | 2008-09 → 2009-04 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
12 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 |
|---|---|---|
| May 2, 2024 | SUPPL -19 | View Letter (PDF) |
| Dec 8, 2015 | SUPPL -17 | View Letter (PDF) |
| Sep 28, 2015 | SUPPL -16 | View Letter (PDF) |
| Nov 21, 2011 | SUPPL -13 | View Letter (PDF) |
| Nov 21, 2011 | SUPPL -12 | View Letter (PDF) |
| Nov 21, 2011 | SUPPL -15 | View Letter (PDF) |
| Jun 13, 2008 | SUPPL -10 | View Letter (PDF) |
| Apr 2, 2008 | SUPPL -11 | View Letter (PDF) |
| Jan 30, 2006 | SUPPL -9 | View Letter (PDF) |
| Jul 21, 2004 | SUPPL -8 | View Letter (PDF) |
| May 27, 2004 | ORIG -1 | View Letter (PDF) |
| Dec 22, 2003 | SUPPL -7 | View Letter (PDF) |
| Jun 8, 2003 | SUPPL -3 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.