Overview
No overview information available.
Indication
No indication information available.
Associated Conditions
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Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2005/09/20 | Phase 3 | Completed | |||
2005/09/20 | Phase 3 | Completed | |||
2005/09/20 | Phase 3 | Completed | |||
2005/09/20 | Phase 3 | Completed | |||
2005/09/20 | Phase 4 | Terminated | |||
2005/09/19 | Phase 3 | Completed | |||
2005/09/15 | Phase 3 | Completed | |||
2005/06/17 | Phase 3 | Completed | |||
2005/04/18 | Phase 3 | Completed | |||
2005/04/08 | Phase 3 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| WOCKHARDT LIMITED | 55648-725 | ORAL | 500 mg in 1 1 | 7/22/2010 | |
| AbbVie Inc. | 0074-6114 | ORAL | 125 mg in 1 1 | 3/29/2024 | |
| Zydus Lifesciences Limited | 65841-634 | ORAL | 125 mg in 1 1 | 9/21/2023 | |
| A-S Medication Solutions | 50090-4737 | ORAL | 500 mg in 1 1 | 5/4/2023 | |
| Preferred Pharmaceuticals Inc. | 68788-7177 | ORAL | 500 mg in 1 1 | 5/16/2023 | |
| Bryant Ranch Prepack | 71335-2344 | ORAL | 500 mg in 1 1 | 12/29/2021 | |
| Aurobindo Pharma Limited | 65862-402 | ORAL | 250 mg in 1 1 | 2/7/2024 | |
| Contract Pharmacy Services-PA | 67046-143 | ORAL | 500 mg in 1 1 | 9/25/2017 | |
| Wockhardt USA LLC. | 64679-975 | ORAL | 500 mg in 1 1 | 4/11/2018 | |
| Cardinal Health 107, LLC | 55154-4759 | ORAL | 125 mg in 1 1 | 1/5/2018 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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