Overview
An antipsychotic phenothiazine derivative with actions and uses similar to those of chlorpromazine.
Indication
For use in the management of the manifestations of psychotic disorders and for the control of severe nausea and vomiting in adults.
Associated Conditions
- Anxiety
- Depression
- Schizophrenia
- Moderate Agitation
- Moderate Anxiety
- Moderate Depressed mood
- Severe Anxiety
- Severe Depressed mood
- Severe Nausea and vomiting
- Severe agitation
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/03/09 | Phase 2 | Recruiting | |||
2021/03/01 | Phase 1 | Completed | |||
2020/10/28 | Phase 3 | Recruiting | Jennifer Holder-Murray | ||
2016/09/08 | N/A | Terminated | |||
2015/11/09 | N/A | Completed | |||
2015/05/01 | Phase 3 | Completed | |||
2015/03/02 | Phase 3 | Terminated | |||
2014/12/04 | Phase 4 | Completed | Technical University of Munich | ||
2014/07/24 | Phase 4 | Completed | |||
2010/09/01 | Phase 4 | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| State of Florida DOH Central Pharmacy | 53808-0665 | ORAL | 4 mg in 1 1 | 8/18/2010 | |
| Mylan Pharmaceuticals Inc. | 0378-0042 | ORAL | 4 mg in 1 1 | 9/26/2019 | |
| Actavis Pharma, Inc. | 0591-4103 | ORAL | 8 mg in 1 1 | 5/31/2017 | |
| Proficient Rx LP | 71205-843 | ORAL | 8 mg in 1 1 | 2/1/2023 | |
| Bryant Ranch Prepack | 72162-1163 | ORAL | 4 mg in 1 1 | 9/16/2022 | |
| State of Florida DOH Central Pharmacy | 53808-0762 | ORAL | 16 mg in 1 1 | 8/18/2010 | |
| Zydus Pharmaceuticals (USA) Inc. | 68382-594 | ORAL | 16 mg in 1 1 | 9/30/2023 | |
| Major Pharmaceuticals | 0904-6601 | ORAL | 8 mg in 1 1 | 12/18/2018 | |
| Mylan Pharmaceuticals Inc. | 0378-0442 | ORAL | 2 mg in 1 1 | 9/26/2019 | |
| Bryant Ranch Prepack | 63629-2251 | ORAL | 4 mg in 1 1 | 4/6/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| APO-PERPHENAZINE TABLET 8 mg | SIN00437P | TABLET, FILM COATED | 8 mg | 4/27/1988 | |
| APO-PERPHENAZINE TABLET 4 mg | SIN00444P | TABLET, FILM COATED | 4 mg | 4/27/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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