ESOMEPRAZOLE MAGNESIUM | N214278 | DEXCEL PHARMA TECHNOLOGIES LTD
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 2 | Recruiting | Stanford University | 25 | 2019-05-29 → 2028-12 | |
| N/A | Recruiting | Seoul National University Bundang Hospital | 600 | 2014-08 → 2027-12 | |
| Phase 4 | Completed | AstraZeneca | 441 | 2006-08 → 2007-08 | |
| Phase 3 | Completed | AstraZeneca | 1,398 | 2012-08 → 2014-05 | |
| Phase 1 | Completed | Addpharma Inc. | 88 | 2019-06-05 → 2020-06-18 | |
| Phase 3 | Completed | AstraZeneca | 343 | 2014-07 → 2016-02 | |
| Phase 4 | Completed | AstraZeneca | 450 | 2005-12 → 2007-02 | |
| Phase 1 | Completed | AstraZeneca | 28 | 2011-05 → 2011-06 | |
| N/A | Completed | King Faisal Specialist Hospital & Research Center | 55 | 2013-06 → 2014-04 | |
| Phase 4 | Completed | AstraZeneca | 750 | 2002-12 → 2004-01 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
29 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 12, 2022 | SUPPL -2 | View Letter (PDF) |
| Sep 9, 2021 | SUPPL -1 | View Letter (PDF) |
| Oct 21, 2020 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.