Overview
No overview information available.
Indication
No indication information available.
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 |
|---|---|---|---|---|---|
| Promius Pharma, LLC | 67857-700 | ORAL | 200 mg in 1 1 | 1/12/2012 | |
| Physicians Total Care, Inc. | 54868-4216 | ORAL | 400 mg in 1 1 | 9/24/2012 | |
| ANI Pharmaceuticals, Inc. | 62559-255 | ORAL | 200 mg in 1 1 | 7/20/2022 | |
| ANI Pharmaceuticals, Inc. | 62559-256 | ORAL | 400 mg in 1 1 | 7/20/2022 | |
| Amneal Pharmaceuticals of New York LLC | 53746-669 | ORAL | 200 mg in 1 1 | 12/12/2023 | |
| Amneal Pharmaceuticals of New York LLC | 53746-670 | ORAL | 400 mg in 1 1 | 12/12/2023 | |
| AvPAK | 50268-050 | ORAL | 200 mg in 1 1 | 1/9/2024 | |
| Physicians Total Care, Inc. | 54868-5520 | ORAL | 200 mg in 1 1 | 9/24/2012 | |
| Marlex Pharmaceuticals Inc | 10135-630 | ORAL | 200 mg in 1 1 | 9/13/2021 | |
| Marlex Pharmaceuticals Inc | 10135-631 | ORAL | 400 mg in 1 1 | 9/13/2021 |
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 |
|---|---|---|---|---|---|
| RHOTRAL 100 | sanofi-aventis canada inc | 01910140 | Tablet - Oral | 100 MG | 12/31/1991 |
| MONITAN TAB 400MG | wyeth ltd. | 00771341 | Tablet - Oral | 400 MG | 12/31/1990 |
| RHOTRAL 400 | sanofi-aventis canada inc | 01910167 | Tablet - Oral | 400 MG | 12/31/1995 |
| MONITAN TAB 200MG | wyeth ltd. | 00695653 | Tablet - Oral | 200 MG | 12/31/1987 |
| RHOTRAL 200 | sanofi-aventis canada inc | 01910159 | Tablet - Oral | 200 MG | 12/31/1991 |
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. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.