ARIPIPRAZOLE | N021866 | OTSUKA PHARMACEUTICAL CO LTD
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 4 | Completed | Johns Hopkins University | 127 | 2009-01 → 2014-03 | |
| Phase 4 | Completed | Lindner Center of HOPE | 31 | 2006-08 → 2009-03 | |
| Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 400 | 2005-03 → 2007-11 | |
| Phase 4 | Completed | Washington University School of Medicine | 742 | 2017-02-24 → 2021-09-01 | |
| Phase 4 | Completed | Institute of Mental Health, Singapore | 67 | 2016-08 → 2020-01-01 | |
| Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 232 | 2000-08 → 2010-07 | |
| Phase 4 | Completed | Chonbuk National University Hospital | 82 | 2018-06-01 → 2020-09-30 | |
| Phase 1 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 36 | 2017-06-14 → 2018-05-02 | |
| Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 1,200 | 2002-09 → 2006-11 | |
| Phase 2 | Completed | New York State Psychiatric Institute | 26 | 2005-04 → 2008-09 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
40 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 |
|---|---|---|
| Feb 6, 2020 | SUPPL -30 | View Letter (PDF) |
| Feb 6, 2020 | SUPPL -29 | View Letter (PDF) |
| Aug 8, 2019 | SUPPL -28 | View Letter (PDF) |
| Mar 2, 2017 | SUPPL -27 | View Letter (PDF) |
| Aug 18, 2016 | SUPPL -26 | View Letter (PDF) |
| Jan 20, 2016 | SUPPL -25 | View Letter (PDF) |
| Dec 15, 2014 | SUPPL -23 | View Letter (PDF) |
| Jul 11, 2014 | SUPPL -21 | View Letter (PDF) |
| Aug 5, 2013 | SUPPL -22 | View Letter (PDF) |
| Feb 27, 2012 | SUPPL -20 | View Letter (PDF) |
| Mar 8, 2011 | SUPPL -19 | View Letter (PDF) |
| Feb 18, 2011 | SUPPL -16 | View Letter (PDF) |
| Dec 7, 2010 | SUPPL -18 | View Letter (PDF) |
| Dec 3, 2010 | SUPPL -17 | View Letter (PDF) |
| Feb 17, 2010 | SUPPL -15 | View Letter (PDF) |
| Feb 14, 2010 | SUPPL -3 | View Letter (PDF) |
| Jul 24, 2009 | SUPPL -14 | View Letter (PDF) |
| Aug 19, 2008 | SUPPL -13 | View Letter (PDF) |
| May 14, 2008 | SUPPL -7 | View Letter (PDF) |
| May 14, 2008 | SUPPL -6 | View Letter (PDF) |
| May 14, 2008 | SUPPL -9 | View Letter (PDF) |
| Mar 7, 2008 | SUPPL -10 | View Letter (PDF) |
| Feb 29, 2008 | SUPPL -8 | View Letter (PDF) |
| Nov 19, 2007 | SUPPL -5 | View Letter (PDF) |
| Nov 8, 2007 | SUPPL -4 | View Letter (PDF) |
| Oct 4, 2007 | SUPPL -2 | View Letter (PDF) |
| Sep 25, 2006 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.