Overview
Nortriptyline hydrochloride, the active metabolite of amitriptyline, is a tricyclic antidepressant (TCA). It is used in the treatment of major depression and is also used off-label for chronic pain and other conditions.
Background
Nortriptyline hydrochloride, the active metabolite of amitriptyline, is a tricyclic antidepressant (TCA). It is used in the treatment of major depression and is also used off-label for chronic pain and other conditions.
Indication
Nortriptyline is indicated for the relief of the symptoms of major depressive disorder (MDD). Some off-label uses for this drug include treatment of chronic pain, myofascial pain, neuralgia, and irritable bowel syndrome.
Associated Conditions
- Chronic Pain
- Irritable Bowel Syndrome (IBS)
- Major Depressive Disorder (MDD)
- Myofascial Pain Syndrome
- Pain, Orofacial
- Postherpetic Neuralgia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/29 | Phase 4 | Recruiting | |||
2022/10/17 | Phase 4 | Recruiting | |||
2022/09/08 | Phase 4 | Completed | |||
2020/05/27 | Phase 4 | Recruiting | |||
2020/01/13 | Phase 4 | Terminated | |||
2019/02/18 | Phase 2 | Completed | |||
2018/08/29 | Phase 3 | UNKNOWN | |||
2018/08/29 | Phase 3 | Completed | |||
2016/11/10 | Phase 4 | Completed | |||
2016/09/28 | Phase 4 | Completed | Federal University of Rio Grande do Sul |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| AvPAK | 50268-603 | ORAL | 10 mg in 1 1 | 1/8/2024 | |
| DIRECT RX | 72189-177 | ORAL | 50 mg in 1 1 | 2/9/2021 | |
| Taro Pharmaceuticals U.S.A., Inc. | 51672-4002 | ORAL | 25 mg in 1 1 | 5/4/2020 | |
| Zydus Pharmaceuticals (USA) Inc. | 70710-1155 | ORAL | 50 mg in 1 1 | 3/27/2024 | |
| Direct_Rx | 61919-285 | ORAL | 25 mg in 1 1 | 10/5/2022 | |
| Taro Pharmaceuticals U.S.A., Inc. | 51672-4003 | ORAL | 50 mg in 1 1 | 5/4/2020 | |
| Direct_Rx | 61919-742 | ORAL | 50 mg in 1 1 | 3/11/2019 | |
| Proficient Rx LP | 63187-322 | ORAL | 10 mg in 1 1 | 1/1/2019 | |
| A-S Medication Solutions | 50090-1323 | ORAL | 50 mg in 1 1 | 5/4/2020 | |
| Proficient Rx LP | 71205-254 | ORAL | 25 mg in 1 1 | 6/1/2022 |
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-NORTRIPTYLINE CAPSULE 10 mg | SIN09255P | CAPSULE | 10 mg | 3/18/1997 | |
| APO-NORTRIPTYLINE CAPSULE 25 mg | SIN09253P | CAPSULE | 25 mg | 3/18/1997 |
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. | |||||