ZIPRASIDONE HYDROCHLORIDE | N021483 | PFIZER INC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 1 | Recruiting | University of Arizona | 24 | 2017-11-20 → 2026-02-10 | |
| Phase 3 | Completed | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | 680 | 2006-04 → 2008-12 | |
| Phase 2 | Completed | Vanderbilt University | 102 | 2004-12 → 2007-07 | |
| Phase 2/3 | Completed | Manhattan Psychiatric Center | 57 | 2003-09 → 2010-01 | |
| N/A | Completed | Washington University School of Medicine | 46 | 2009-02 → 2012-06 | |
| Phase 4 | Completed | Central Institute of Mental Health, Mannheim | 24 | 2003-11 → 2006-09 | |
| Phase 3 | Completed | Vanda Pharmaceuticals | 593 | 2005-11-18 → 2007-03-21 | |
| Phase 3 | Completed | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | 298 | 2007-10 → 2008-12 | |
| Phase 2 | Completed | Tufts Medical Center | 73 | 2006-12 → 2009-08 | |
| Phase 3 | Completed | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | 242 | 2004-07 → 2005-05 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
12 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 2, 2017 | SUPPL -15 | View Letter (PDF) |
| Aug 24, 2015 | SUPPL -14 | View Letter (PDF) |
| Dec 11, 2014 | SUPPL -13 | View Letter (PDF) |
| Aug 16, 2013 | SUPPL -10 | View Letter (PDF) |
| Jul 5, 2013 | SUPPL -7 | View Letter (PDF) |
| Mar 5, 2013 | SUPPL -9 | View Letter (PDF) |
| Dec 7, 2010 | SUPPL -5 | View Letter (PDF) |
| Nov 24, 2009 | SUPPL -3 | View Letter (PDF) |
| Apr 5, 2006 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.