RANITIDINE HYDROCHLORIDE | N020520 | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 1 | Recruiting | Russell Richardson | 420 | 2008-09 → 2026-08 | |
| Phase 3 | Completed | AstraZeneca | 400 | 2001-02 → 2003-03 | |
| N/A | Completed | University of Edinburgh | 24 | 2011-01-03 → 2011-07-15 | |
| N/A | Completed | Radboud University Medical Center | 664 | 2003-10 → 2007-01 | |
| Phase 1 | Completed | Boehringer Ingelheim | 18 | 2000-07 | |
| Phase 2 | Completed | National Cancer Institute (NCI) | 102 | 2002-02 → 2012-06 | |
| Phase 4 | Completed | King Saud University | 1,920 | 2012-01 → 2015-12 | |
| Phase 2 | Completed | Hamilton Health Sciences Corporation | 43 | 2012-02 → 2021-09 | |
| Phase 4 | Completed | Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec | 320 | 2009-06 → 2011-12 | |
| Phase 3 | Completed | AstraZeneca | 397 | 2006-03 → 2008-11 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
3 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 |
|---|---|---|
| Sep 19, 2019 | SUPPL -38 | View Letter (PDF) |
| Apr 8, 2019 | SUPPL -37 | View Letter (PDF) |
| Jul 28, 2016 | SUPPL -33 | View Letter (PDF) |
| Feb 17, 2016 | SUPPL -32 | View Letter (PDF) |
| Nov 23, 2015 | SUPPL -30 | View Letter (PDF) |
| Feb 3, 2015 | SUPPL -28 | View Letter (PDF) |
| Mar 3, 2005 | SUPPL -15 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.