Overview
Butamben is a local anesthetic in the form of n-butyl-p-aminobenzoate. Its structure corresponds to the standard molecule of a hydrophilic and hydrophobic domain separated by an intermediate ester found in most of the local anesthetics. Due to its very low water solubility, butamben is considered to be suitable only for topical anesthesia. The FDA removed all parenteral butamben products from the market, possibly due to the poor solubility of this drug.
Indication
Butamben was indicated for the treatment of chronic pain due to its long-duration effect. It is also indicated as a surface anesthetic for skin a mucous membrane and for the relief of pain and pruritus associated with anorectal disorders.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|
No clinical trials found
No clinical trials found for this drug
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Cetylite Industries, Inc. | 10223-0202 | TOPICAL | 0.004 g in 0.2 g | 5/11/2023 | |
| HAGER WORLDWIDE, INC. | 62565-904 | TOPICAL, DENTAL | 4 mg in .2 g | 11/23/2011 | |
| Cetylite Industries, Inc. | 10223-0221 | TOPICAL | 0.004 g in 0.2 g | 1/17/2022 | |
| Cetylite Industries, Inc. | 10223-0201 | TOPICAL | 0.004 g in 0.2 g | 1/17/2022 | |
| Cetylite Industries, Inc. | 10223-0226 | TOPICAL | 0.004 g in 0.2 g | 5/11/2023 | |
| HAGER WORLDWIDE, INC. | 62565-903 | TOPICAL, DENTAL | 4 mg in .2 g | 11/23/2011 | |
| HAGER WORLDWIDE, INC. | 62565-901 | TOPICAL, DENTAL | 4 mg in .2 g | 11/16/2011 | |
| HAGER WORLDWIDE, INC. | 62565-902 | TOPICAL, DENTAL | 4 mg in .2 g | 11/23/2011 | |
| Cetylite Industries, Inc. | 10223-0217 | TOPICAL | 0.004 g in 0.2 g | 1/17/2022 | |
| Cetylite Industries, Inc. | 10223-0225 | TOPICAL | 0.004 g in 0.2 g | 5/11/2023 |
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 |
|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| CETACAINE LIQUID | cetylite industries inc. | 02028867 | Liquid - Topical | 2 % | 9/19/1996 |
| CETACAINE SPRAY | cetylite industries inc. | 02028840 | Aerosol - Topical | 2 % | 12/31/1994 |
| ALVOGYL | 00555509 | Paste - Dental | 25.7 G / 100 G | 12/31/1973 |
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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