ERYTHROMYCIN | N050611 | AZURITY PHARMACEUTICALS INC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 3 | Active | Inova Health Care Services | 140 | 2024-03-08 → 2027-10-01 | |
| Phase 4 | By Invitation | Universitaire Ziekenhuizen KU Leuven | 15 | 2014-03 → 2025-03 | |
| Phase 4 | Recruiting | Centre for Human Drug Research, Netherlands | 30 | 2018-03-20 → 2019-12 | |
| Phase 1/2 | Recruiting | Genmab | 952 | 2022-12-07 → 2027-10 | |
| Phase 1 | Completed | Pfizer | 12 | 2012-06 → 2012-08 | |
| N/A | Completed | Virginia Commonwealth University | 18 | 2013-04 → 2015-06 | |
| Phase 1 | Completed | Adil Bharucha | 30 | 2010-06 → 2013-11 | |
| Phase 4 | Completed | Baqiyatallah Medical Sciences University | — | — | |
| Phase 4 | Completed | University of California, San Francisco | 401 | 2017-10-02 → 2019-11-14 | |
| N/A | Completed | University Hospital, Gasthuisberg | 250 | 2012-11 → 2017-05 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
10 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 |
|---|---|---|
| Apr 24, 2018 | SUPPL -36 | View Letter (PDF) |
| Feb 6, 2012 | SUPPL -35 | View Letter (PDF) |
| Feb 7, 2011 | SUPPL -27 | View Letter (PDF) |
| Nov 8, 2010 | SUPPL -31 | View Letter (PDF) |
| Dec 19, 2008 | SUPPL -32 | View Letter (PDF) |
| May 28, 2008 | SUPPL -30 | View Letter (PDF) |
| Jan 9, 2008 | SUPPL -29 | View Letter (PDF) |
| Aug 14, 2006 | SUPPL -22 | View Letter (PDF) |
| Mar 16, 2004 | SUPPL -24 | View Letter (PDF) |
| Apr 25, 2002 | SUPPL -19 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.