Overview
Carbamazepine, also known as Tegretol, is an anticonvulsant drug and analgesic drug used to control seizures and to treat pain resulting from trigeminal neuralgia. It was initially approved by the FDA in 1965. Aside from the above uses, this drug is also given to control the symptoms of bipolar 1. Interestingly, carbamazepine was the first anticonvulsant used to treat individuals with bipolar disorder.
Indication
Carbamazepine is indicated for the treatment of epilepsy and pain associated with true trigeminal neuralgia. In particular, carbamazepine has shown efficacy in treating mixed seizures, partial seizures with complex symptoms, and generalized tonic-clonic seizures. Carbamazepine is also indicated for the treatment of manic episodes and mixed manic-depressive episodes caused by bipolar I disorder. Some off-label, unapproved uses of carbamazepine include the treatment of alcohol withdrawal syndrome and restless leg syndrome.
Associated Conditions
- Acute Mania
- Alcohol Withdrawal Syndrome
- Complex Partial Seizure Disorder
- Generalized Tonic-Clonic Seizures
- Mixed manic depressive episode
- Pain
- Partial Seizures With Secondary Generalization
- Restless Legs Syndrome (RLS)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/06 | Phase 1 | Completed | |||
2025/03/25 | Phase 1 | Active, not recruiting | |||
2025/02/27 | Phase 4 | Active, not recruiting | |||
2025/02/26 | Phase 1 | Completed | |||
2024/12/27 | Phase 1 | Completed | |||
2024/11/04 | Phase 1 | Active, not recruiting | |||
2024/11/04 | Phase 1 | Completed | |||
2024/10/17 | Phase 1 | Completed | |||
2024/10/09 | Phase 1 | Completed | |||
2024/09/19 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bryant Ranch Prepack | 71335-1730 | ORAL | 200 mg in 1 1 | 12/21/2021 | |
| Ajanta Pharma USA Inc. | 27241-233 | ORAL | 400 mg in 1 1 | 12/14/2023 | |
| State of Florida DOH Central Pharmacy | 53808-0915 | ORAL | 200 mg in 1 1 | 5/20/2010 | |
| REMEDYREPACK INC. | 70518-3335 | ORAL | 200 mg in 1 1 | 3/15/2024 | |
| Prasco Laboratories | 66993-407 | ORAL | 100 mg in 1 1 | 5/15/2023 | |
| REMEDYREPACK INC. | 70518-3146 | ORAL | 200 mg in 1 1 | 3/13/2024 | |
| NCS HealthCare of KY, LLC dba Vangard Labs | 0615-3505 | ORAL | 200 mg in 1 1 | 9/13/2023 | |
| Coupler LLC | 67046-1559 | ORAL | 200 mg in 1 1 | 4/29/2025 | |
| Taro Pharmaceuticals U.S.A., Inc. | 51672-4005 | ORAL | 200 mg in 1 1 | 3/29/2024 | |
| UMEDICA LABORATORIES PRIVATE LIMITED | 60290-060 | ORAL | 400 mg in 1 1 | 1/2/2024 |
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-CARBAMAZEPINE TABLET 200 mg | SIN05735P | TABLET | 200 mg | 4/8/1991 | |
| TEGRETOL CR 400 TABLET 400 mg | SIN02388P | TABLET, FILM COATED | 400 mg | 11/10/1988 | |
| TEGRETOL 200 TABLET 200 mg | SIN00352P | TABLET | 200 mg | 4/26/1988 | |
| TEGRETOL CR 200 TABLET 200 mg | SIN02387P | TABLET, FILM COATED | 200 mg | 11/10/1988 | |
| Tegretol Oral Suspension 2% | SIN00510P | SUSPENSION | 2 g/100 ml | 4/28/1988 | |
| STORILAT 200 TABLET 200 mg | SIN05583P | TABLET | 200 mg | 2/18/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Carbamazepine Capsules | 国药准字H13022515 | 化学药品 | 胶囊剂 | 7/22/2020 | |
| Carbamazepine Capsules | 国药准字H21021204 | 化学药品 | 胶囊剂 | 3/4/2024 | |
| Carbamazepine Capsules | 国药准字H12020833 | 化学药品 | 胶囊剂 | 7/20/2020 | |
| Carbamazepine Capsules | 国药准字H12020241 | 化学药品 | 胶囊剂 | 6/17/2020 | |
| Carbamazepine Capsules | 国药准字H32022651 | 化学药品 | 胶囊剂 | 7/14/2020 | |
| Carbamazepine Capsules | 国药准字H37023627 | 化学药品 | 胶囊剂 | 11/9/2021 | |
| Carbamazepine Capsules | 国药准字H37020486 | 化学药品 | 胶囊剂 | 3/1/2020 | |
| Carbamazepine Capsules | 国药准字H34022482 | 化学药品 | 胶囊剂 | 6/29/2020 | |
| Carbamazepine Capsules | 国药准字H11021655 | 化学药品 | 胶囊剂 | 12/8/2020 | |
| Carbamazepine Capsules | 国药准字H13020730 | 化学药品 | 胶囊剂 | 7/31/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| TEGRETOL TAB 200MG | N/A | N/A | N/A | 4/27/1999 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| TEGRETOL CR 400 carbamazepine 400 mg tablet blister pack | 42944 | Medicine | A | 11/24/1993 | |
| CARBAMAZEPINE SANDOZ carbamazepine 200mg tablet blister pack | 78211 | Medicine | A | 4/20/2001 | |
| TEGRETOL CR 200 carbamazepine 200 mg tablet blister pack | 42974 | Medicine | A | 11/24/1993 | |
| TERIL carbamazepine 200mg tablet bottle | 17674 | Medicine | A | 9/20/1991 | |
| TEGRETOL LIQUID carbamazepine 20 mg/mL oral liquid bottle | 59160 | Medicine | A | 3/26/1997 | |
| TEGRETOL 200 carbamazepine 200 mg tablet blister pack | 41848 | Medicine | A | 9/9/1992 | |
| TEGRETOL 100 carbamazepine 100 mg tablet blister pack | 41846 | Medicine | A | 9/9/1992 | |
| TEGRETOL 200 carbamazepine 200mg tablet bottle | 11062 | Medicine | A | 8/2/1991 | |
| AVLOIRE carbamazepine 200 mg tablet blister pack | 434691 | Medicine | A | 3/12/2024 | |
| CARBAMAZEPINE SANDOZ carbamazepine 100mg tablet blister pack | 78217 | Medicine | A | 4/20/2001 |
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