Overview
No overview information available.
Background
No background information available.
Indication
Isosulfan Blue is a synthetic visual lymphatic imaging agent. Isosulfan blue upon subcutaneous administration, delineates the lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; lymph node response to therapeutic modalities.
Associated Conditions
- Chylothorax
- Chylous Ascites
- Chyluria
- Secondary and unspecified malignant neoplasm of lymph nodes
- Lymph node response to therapeutic modalities
- Lymphedema of the extremities
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/04/25 | Phase 3 | Active, not recruiting | |||
2013/09/11 | Not Applicable | Terminated | |||
2013/03/26 | Not Applicable | Completed | |||
2013/01/18 | Phase 2 | Completed | |||
2008/02/28 | Phase 2 | UNKNOWN | |||
2007/03/22 | Not Applicable | Completed | |||
2007/02/22 | Not Applicable | Completed | |||
2004/05/19 | Not Applicable | Completed | |||
2003/10/07 | Not Applicable | Terminated | |||
2003/01/27 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| AuroMedics Pharma LLC | 55150-240 | SUBCUTANEOUS | 50 mg in 5 mL | 12/5/2019 | |
| AnazaoHealth Corporation | 51808-206 | SUBCUTANEOUS | 10 mg in 1 mL | 7/9/2012 | |
| Eugia US LLC | 55150-240 | SUBCUTANEOUS | 50 mg in 5 mL | 2/15/2024 | |
| Mylan Institutional LLC | 67457-220 | SUBCUTANEOUS | 10 mg in 1 mL | 7/19/2017 | |
| Meitheal Pharmaceuticals Inc. | 71288-805 | SUBCUTANEOUS | 10 mg in 1 mL | 11/3/2021 | |
| UNITED STATES SURGICAL CORPORATION | 63261-250 | SUBCUTANEOUS | 10 mg in 1 mL | 12/23/2011 | |
| Somerset Therapeutics, LLC | 70069-221 | SUBCUTANEOUS | 10 mg in 1 mL | 7/23/2019 |
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 |
|---|---|---|---|---|---|
| Isosulfan Blue Injection | 国药准字H20243183 | 化学药品 | 注射剂 | 2/20/2024 |
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. | |||||