Overview
A cardioselective beta-1-adrenergic antagonist with no partial agonist activity.
Indication
For the management of hypertension.
Associated Conditions
- Hypertension
- Increased Intra Ocular Pressure (IOP)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2015/12/01 | Phase 3 | Completed | Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. | ||
2012/08/08 | Phase 1 | Completed | Smith-Kettlewell Eye Research Institute | ||
2003/05/30 | Phase 3 | Completed | |||
1999/09/24 | Phase 3 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| PuraCap Laboratories LLC | 24658-700 | ORAL | 10 mg in 1 1 | 10/31/2019 | |
| KVK-TECH, INC. | 10702-014 | ORAL | 20 mg in 1 1 | 2/14/2024 | |
| PuraCap Laboratories LLC | 24658-701 | ORAL | 20 mg in 1 1 | 10/31/2019 | |
| Sandoz Inc | 61314-245 | OPHTHALMIC | 5.6 mg in 1 mL | 10/31/2023 | |
| Physicians Total Care, Inc. | 54868-4932 | ORAL | 10 mg in 1 1 | 5/15/2012 | |
| Marlex Pharmaceuticals Inc | 10135-624 | ORAL | 20 mg in 1 1 | 10/5/2016 | |
| Akorn | 17478-705 | OPHTHALMIC | 5 mg in 1 mL | 5/23/2022 | |
| Epic Pharma LLC | 42806-038 | ORAL | 10 mg in 1 1 | 1/3/2019 | |
| KVK-TECH, INC. | 10702-013 | ORAL | 10 mg in 1 1 | 2/14/2024 | |
| Marlex Pharmaceuticals Inc | 10135-623 | ORAL | 10 mg in 1 1 | 10/5/2016 |
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 |
|---|---|---|---|---|---|
| BETAC FILM COATED TABLET 20 mg | SIN12621P | TABLET, FILM COATED | 20 mg | 12/7/2004 | |
| BETOPTIC S STERILE OPHTHALMIC SUSPENSION 0.25% | SIN05837P | SOLUTION | 0.25% w/v | 5/18/1991 |
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 |
|---|---|---|---|---|---|
| BETOQUIN betaxolol 5.0mg/mL (as hydrochloride) eye drops solution bottle | 55618 | Medicine | A | 6/13/1996 | |
| BETOPTIC betaxolol 5mg/mL (as hydrochloride) eye drops bottle | 25272 | Medicine | A | 10/15/1991 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
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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