ARIPIPRAZOLE | N211448 | CMG 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 |
|---|---|---|
| Apr 28, 2025 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 9694008 | Aug 7, 2033 | — | — | Yes | — | — |