CIPROFLOXACIN HYDROCHLORIDE | N021744 | DEPOMED INC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| N/A | Active | Jordan University of Science and Technology | 40 | 2010-06-28 → 2030-12-01 | |
| Early Phase 1 | Active | The Cleveland Clinic | 100 | 2011-02-11 → 2029-12 | |
| Phase 4 | Completed | Rennes University Hospital | 31 | 2015-06 → 2016-12 | |
| Phase 4 | Completed | Radboud University Medical Center | 1,538 | 2018-04-03 → 2021-09-26 | |
| Phase 3 | Completed | Pfizer | 641 | 2012-10 → 2014-08 | |
| Phase 4 | Completed | Tariq Yehia | 40 | 2015-01-16 → 2018-01-01 | |
| Phase 2 | Completed | Otonomy, Inc. | 95 | 2016-02 → 2016-07 | |
| N/A | Completed | Loma Linda University | 120 | 2014-10 → 2016-05 | |
| N/A | Completed | University of Pennsylvania | 201 | 2014-12 → 2020-09-30 | |
| Phase 4 | Completed | Ottawa Hospital Research Institute | 458 | 2016-09 → 2020-04 |
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 |
|---|---|---|
| Mar 3, 2011 | SUPPL -16 | View Letter (PDF) |
| Jan 4, 2011 | SUPPL -14 | View Letter (PDF) |
| May 13, 2009 | SUPPL -13 | View Letter (PDF) |
| Oct 23, 2008 | SUPPL -7 | View Letter (PDF) |
| Oct 23, 2008 | SUPPL -10 | View Letter (PDF) |
| Oct 8, 2008 | SUPPL -8 | View Letter (PDF) |
| Sep 6, 2007 | SUPPL -5 | View Letter (PDF) |
| Aug 2, 2007 | SUPPL -3 | View Letter (PDF) |
| Aug 21, 2006 | SUPPL -2 | View Letter (PDF) |
| May 20, 2005 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.