Overview
Oxybuprocaine (also known as Benoxinate) is a local anesthetic, which is used especially in ophthalmology and otolaryngology. Oxybuprocaine binds to sodium channels and reversibly stabilizes the neuronal membrane which decreases its permeability to sodium ions.
Indication
Used to temporarily numb the front surface of the eye so that the eye pressure can be measured or a foreign body removed.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/06/17 | Phase 3 | Completed | |||
2023/07/03 | Phase 3 | Completed | |||
2022/12/27 | Phase 4 | Completed | |||
2019/12/10 | Not Applicable | Completed | |||
2019/05/01 | Phase 2 | Completed | |||
2015/08/19 | Not Applicable | Completed | |||
2013/07/26 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bausch & Lomb Incorporated | 24208-734 | OPHTHALMIC | 4.4 mg in 1 mL | 8/31/2022 | |
| Oceanside Pharmaceuticals | 68682-732 | OPHTHALMIC | 4.4 mg in 1 mL | 3/19/2020 | |
| Bausch & Lomb Americas Inc. | 82260-734 | OPHTHALMIC | 4.4 mg in 1 mL | 3/16/2023 | |
| Altaire Pharmaceuticals Inc. | 59390-218 | OPHTHALMIC | 4 mg in 1 mL | 12/2/2022 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| Minims Oxybuprocaine Hydrochloride 0.4% 4mg/mL eye drops tube | 32259 | Medicine | A | 10/30/1991 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| FLUOROX | white ophthalmic services & supply co ltd | 02354993 | Solution - Ophthalmic | 0.4 % | 11/28/2011 |
| MINIMS BENOXINATE HYDROCHLORIDE 0.4% | chauvin pharmaceuticals limited | 02148366 | Drops - Topical
,
Ophthalmic | .4 % | 12/31/1995 |
| FLUORESCEIN SODIUM & BENOXINATE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP | bausch & lomb inc | 02237775 | Solution - Ophthalmic | 0.4 % | 10/27/1998 |
| FLURESS LIQ OPH | pilkington barnes hind | 02053772 | Liquid - Ophthalmic | 0.4 % | 12/31/1969 |
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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