AMOXICILLIN | N050754 | US ANTIBIOTICS LLC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 3 | Active | National Cancer Center, Korea | 470 | 2003-06 → 2030-06 | |
| N/A | Active | Washington University School of Medicine | 1,500 | 2023-12-05 → 2027-01 | |
| Phase 4 | Not Yet Recruiting | University of Illinois at Chicago | 236 | 2026-08-03 → 2029-08-03 | |
| Phase 4 | Not Yet Recruiting | Nader Shaikh | 1,100 | 2026-10-01 → 2032-03-17 | |
| Phase 4 | Not Yet Recruiting | Nader Shaikh | 1,100 | 2026-10-01 → 2032-03-17 | |
| Phase 4 | Not Yet Recruiting | Qilu Hospital of Shandong University | 316 | 2026-08-01 → 2028-08-10 | |
| Phase 4 | Not Yet Recruiting | University of Sao Paulo General Hospital | 352 | 2026-08-20 → 2029-12-30 | |
| Phase 4 | Not Yet Recruiting | Qilu Hospital of Shandong University | 492 | 2026-09-01 → 2027-12-30 | |
| Phase 3 | Not Yet Recruiting | Assistance Publique - Hôpitaux de Paris | 57 | 2026-12 → 2029-09 | |
| N/A | Recruiting | Seoul National University Bundang Hospital | 600 | 2014-08 → 2027-12 |
Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.
11 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 -22 | View Letter (PDF) |
| Nov 3, 2022 | SUPPL -21 | View Letter (PDF) |
| Dec 8, 2015 | SUPPL -20 | View Letter (PDF) |
| Sep 28, 2015 | SUPPL -19 | View Letter (PDF) |
| Nov 21, 2011 | SUPPL -14 | View Letter (PDF) |
| Nov 21, 2011 | SUPPL -13 | View Letter (PDF) |
| Nov 21, 2011 | SUPPL -17 | View Letter (PDF) |
| Jun 13, 2008 | SUPPL -11 | View Letter (PDF) |
| Apr 2, 2008 | SUPPL -12 | View Letter (PDF) |
| Jul 21, 2004 | SUPPL -9 | View Letter (PDF) |
| May 27, 2004 | SUPPL -1 | View Letter (PDF) |
| Dec 22, 2003 | SUPPL -8 | View Letter (PDF) |
| Jun 8, 2003 | SUPPL -4 | View Letter (PDF) |
| Jul 10, 1998 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.