AMOXICILLIN | N050761 | US ANTIBIOTICS LLC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 3 | Active | Hospital de Niños R. Gutierrez de Buenos Aires | 120 | 2024-08-14 → 2028-06-01 | |
| Phase 2 | Active | Ain Shams University | 90 | 2023-08-15 → 2026-11 | |
| Phase 3 | Active | National Cancer Center, Korea | 470 | 2003-06 → 2030-06 | |
| N/A | Active | Seoul National University Bundang Hospital | 141 | 2021-02-01 → 2027-09-28 | |
| N/A | Active | Washington University School of Medicine | 1,500 | 2023-12-05 → 2027-01 | |
| Phase 3 | Active | Bart Koes | 144 | 2025-04-02 → 2027-08 | |
| Phase 4 | Not Yet Recruiting | Kuopio University Hospital | 219 | 2026-11-01 → 2030-12-31 | |
| N/A | Not Yet Recruiting | abdul mateen | 222 | 2026-11-05 → 2027-05-05 | |
| N/A | Not Yet Recruiting | Khyber Medical University Peshawar | 240 | 2026-09-25 → 2027-10-20 | |
| Phase 4 | Not Yet Recruiting | University of Illinois at Chicago | 236 | 2026-10-05 → 2029-08-03 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
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 -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.