Overview
Labetalol is a racemic mixture of 2 diastereoisomers where dilevalol, the R,R' stereoisomer, makes up 25% of the mixture. Labetalol is formulated as an injection or tablets to treat hypertension. Labetalol was granted FDA approval on 1 August 1984.
Indication
Labetalol injections are indicated to control blood pressure in severe hypertension. Labetalol tablets are indicated alone or in combination with antihypertensives like thiazides and loop diuretics to manage hypertension.
Associated Conditions
- Chronic Stable Angina Pectoris
- Hypertension
- Hypertensive Emergency
- Hypertensive crisis
- Pheochromocytoma
- Subarachnoid Hemorrhage
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/24 | Phase 4 | ENROLLING_BY_INVITATION | |||
2025/04/08 | Phase 4 | Not yet recruiting | |||
2024/12/31 | Phase 4 | Recruiting | |||
2024/04/26 | Not Applicable | Not yet recruiting | |||
2024/04/11 | Phase 1 | Recruiting | |||
2024/04/04 | Not Applicable | Recruiting | |||
2024/02/20 | Not Applicable | Not yet recruiting | |||
2023/10/23 | Phase 4 | Recruiting | |||
2023/08/14 | Phase 1 | Recruiting | |||
2023/07/20 | Phase 2 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-6777 | ORAL | 200 mg in 1 1 | 12/31/2015 | |
| Caplin Steriles Limited | 65145-124 | INTRAVENOUS | 5 mg in 1 mL | 9/15/2021 | |
| Bryant Ranch Prepack | 63629-8898 | ORAL | 100 mg in 1 1 | 5/19/2021 | |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-725 | ORAL | 300 mg in 1 1 | 4/8/2022 | |
| Dispensing Solutions, Inc. | 68258-6047 | ORAL | 200 mg in 1 1 | 11/7/2013 | |
| Bryant Ranch Prepack | 63629-8902 | ORAL | 300 mg in 1 1 | 5/19/2021 | |
| Biocon Pharma Inc. | 70377-061 | ORAL | 200 mg in 1 1 | 5/19/2021 | |
| Epic Pharma, LLC | 42806-327 | ORAL | 100 mg in 1 1 | 9/30/2021 | |
| American Health Packaging | 60687-461 | ORAL | 300 mg in 1 1 | 4/26/2023 | |
| Cardinal Health 107, LLC | 55154-4747 | INTRAVENOUS | 5 mg in 1 mL | 1/13/2023 |
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 |
|---|---|---|---|---|---|
| TRANDATE INJECTION 100 mg/20 ml | SIN02281P | INJECTION | 100 mg/20 ml | 7/14/1988 | |
| TRANTALOL TABLET 100 mg | SIN05162P | TABLET | 100 mg | 10/24/1990 |
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 |
|---|---|---|---|---|---|
| TRANDATE TAB 100MG | N/A | N/A | N/A | 12/9/1978 | |
| PHARMANIAGA LABETALOL HYDROCHLORIDE SOLUTION FOR INJECTION/INFUSION 25MG/5ML | N/A | N/A | N/A | 11/13/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PRESOLOL 100 labetalol hydrochloride 100mg bottle | 56475 | Medicine | A | 7/19/1996 | |
| TRANDATE 100mg tablets | 12521 | Medicine | A | 8/13/1991 | |
| TRANDATE 200mg tablets | 12522 | Medicine | A | 8/13/1991 | |
| LABETALOL SXP labetalol hydrochloride 50 mg/10 mL solution for injection glass ampoule | 306952 | Medicine | A | 11/14/2019 | |
| LABETALOL TLB labetalol hydrochloride 50 mg/10 mL solution for injection glass ampoule | 306954 | Medicine | A | 11/14/2019 | |
| LABETALOL RMB labetalol hydrochloride 50 mg/10 mL solution for injection glass ampoule | 306953 | Medicine | A | 11/14/2019 | |
| PRESOLOL 200 labetalol hydrochloride 200mg bottle | 56476 | Medicine | A | 7/19/1996 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| MINT-LABETALOL | mint pharmaceuticals inc | 02503263 | Tablet - Oral | 200 MG | N/A |
| LABETALOL HYDROCHLORIDE INJECTION IN 0.72% SODIUM CHLORIDE | hikma canada limited | 02557037 | Solution - Intravenous | 1 MG / ML | N/A |
| LABETALOL HYDROCHLORIDE INJECTION, USP | Mylan Pharmaceuticals ULC | 02387468 | Solution - Intravenous | 5 MG / ML | 8/29/2012 |
| LABETALOL HYDROCHLORIDE INJECTION IN 5% DEXTROSE | hikma canada limited | 02557029 | Solution - Intravenous | 1 MG / ML | N/A |
| LABETALOL HYDROCHLORIDE INJECTION USP | 02231689 | Solution - Intravenous | 5 MG / ML | 3/17/1998 | |
| LABETALOL HYDROCHLORIDE INJECTION, USP | Strides Pharma Canada Inc | 02340194 | Solution - Intravenous | 5 MG / ML | N/A |
| LABETALOL HYDROCHLORIDE INJECTION USP | 02391090 | Solution - Intravenous | 5 MG / ML | 6/2/2015 | |
| TRANDATE 5MG/ML | shire biochem inc | 02091518 | Liquid - Intravenous | 5 MG / ML | 8/23/1996 |
| TRANDATE TAB 100MG | glaxo canada inc | 01924915 | Tablet - Oral | 100 MG / TAB | 12/31/1984 |
| LABETALOL HYDROCHLORIDE INJECTION USP | Sterimax Inc | 02385120 | Solution - Intravenous | 5 MG / ML | 5/26/2021 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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