Overview
One of the benzodiazepines that is used in the treatment of anxiety disorders. It is a Schedule IV drug in the U.S. and Canada and under the Convention on Psychotropic Substances. It is a intermediate-acting benzodiazepine.
Indication
For the short-term treatment of insomnia, short-term treatment of anxiety or panic attacks, if a benzodiazepine is required, and the alleviation of the symptoms of alcohol- and opiate-withdrawal.
Associated Conditions
- Anxiety Acute
- Severe Anxiety
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2015/03/02 | Phase 3 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| LEXOTAN TABLET 1.5 mg | SIN00385P | TABLET | 1.5 mg | 4/27/1988 | |
| LEXOTAN TABLET 3 mg | SIN00382P | TABLET | 3 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 |
|---|---|---|---|---|---|
| LEXOTAN bromazepam 3mg tablet | 52269 | Pharmaco Australia Ltd | Medicine | A | 5/9/1995 |
| LEXOTAN bromazepam 6mg tablets | 52270 | Pharmaco Australia Ltd | Medicine | A | 5/9/1995 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| BROMAZEPAM | 02171864 | Tablet - Oral | 3 MG | N/A | |
| LECTOPAM TAB 6MG | Hoffmann-La Roche Limited | 00518131 | Tablet - Oral | 6 MG | 12/31/1981 |
| BROMAZEPAM-6 - TAB 6MG | PRO DOC LIMITEE | 02220539 | Tablet - Oral | 6 MG | 12/4/1996 |
| BROMAZEPAM-3 - TAB 3MG | PRO DOC LIMITEE | 02220520 | Tablet - Oral | 3 MG | 12/4/1996 |
| ALTI-BROMAZEPAM 6MG TABLETS | altimed pharma inc. | 02167824 | Tablet - Oral | 6 MG | 12/31/1996 |
| APO-BROMAZEPAM | 02177153 | Tablet - Oral | 1.5 MG | 12/31/1995 | |
| TEVA-BROMAZEPAM | teva canada limited | 02230584 | Tablet - Oral | 3 MG | 3/3/1997 |
| ALTI-BROMAZEPAM 3MG TABLETS | altimed pharma inc. | 02167816 | Tablet - Oral | 3 MG | 12/31/1995 |
| RIVA-BROMAZEPAM 3 MG | laboratoire riva inc. | 02242152 | Tablet - Oral | 3 MG / TAB | N/A |
| MYLAN-BROMAZEPAM | Mylan Pharmaceuticals ULC | 02192705 | Tablet - Oral | 1.5 MG | 12/31/1995 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| BROMAZEPAM TARBIS 3 MG CAPSULAS DURAS EFG | Tarbis Farma S.L. | 79659 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica. Psicótropos | Not Commercialized |
| BROMAZEPAM PENSA 1,5 mg CAPSULAS EFG | Towa Pharmaceutical S.A. | 73324 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica. Psicótropos | Not Commercialized |
| BROMAZEPAM TARBIS 6 MG CAPSULAS DURAS EFG | Tarbis Farma S.L. | 79660 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica. Psicótropos | Not Commercialized |
| BROMAZEPAM TARBIS 1,5 MG CAPSULAS DURAS EFG | Tarbis Farma S.L. | 79661 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica. Psicótropos | Not Commercialized |
| BROMAZEPAM NORMON 1,5 mg CAPSULAS DURAS EFG | Laboratorios Normon S.A. | 73132 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized |
| BROMAZEPAM NORMON 6 mg CAPSULAS DURAS EFG | Laboratorios Normon S.A. | 73129 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized |
| BROMAZEPAM NORMON 3 mg CAPSULAS DURAS EFG | Laboratorios Normon S.A. | 73133 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized |
| BROMAZEPAM PENSA 3 mg CAPSULAS EFG | Towa Pharmaceutical S.A. | 73319 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized |
| BROMAZEPAM STADA 1,5 mg CAPSULAS DURAS EFG | Laboratorio Stada S.L. | 75680 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica. Psicótropos | Not Commercialized |
| LEXATIN 3 mg CAPSULAS DURAS | 55751 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica. Psicótropos | Commercialized |
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. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.