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 |
|---|---|---|---|---|---|
2019/04/18 | Phase 1 | Recruiting | |||
2017/01/06 | Phase 4 | Completed | |||
2014/06/18 | Phase 1 | Withdrawn | |||
2014/03/24 | Phase 2 | Withdrawn | |||
2014/03/05 | Phase 4 | Completed | |||
2013/01/04 | Not Applicable | Completed | |||
2012/05/01 | Phase 4 | Completed | |||
2012/04/27 | Phase 4 | Withdrawn | Bo-Hyun Yoon | ||
2012/04/20 | Phase 1 | Completed | |||
2012/04/20 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8377 | ORAL | 500 mg in 1 1 | 3/13/2023 | |
| Sun Pharmaceutical Industries, Inc. | 62756-796 | ORAL | 125 mg in 1 1 | 12/29/2021 | |
| TYA Pharmaceuticals | 64725-0798 | ORAL | 500 mg in 1 1 | 1/21/2010 | |
| Wockhardt USA LLC. | 64679-724 | ORAL | 250 mg in 1 1 | 11/26/2019 | |
| REMEDYREPACK INC. | 70518-2513 | ORAL | 250 mg in 1 1 | 3/1/2024 | |
| Lupin Pharmaceuticals, Inc. | 68180-260 | ORAL | 250 mg in 1 1 | 1/2/2024 | |
| Direct_Rx | 72189-459 | ORAL | 500 mg in 1 1 | 4/3/2023 | |
| BluePoint Laboratories | 68001-472 | ORAL | 125 mg in 1 1 | 9/30/2023 | |
| DIRECT RX | 61919-809 | ORAL | 250 mg in 1 1 | 8/11/2015 | |
| Alembic Pharmaceuticals Inc. | 62332-821 | ORAL | 125 mg in 1 1 | 5/15/2025 |
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. | |||||
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