| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 214520 | NDA | CORMEDIX | 001 | DEFENCATH | SOLUTION;N/A | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | HEPARIN SODIUM; TAUROLIDINE | 2023-11-15 | Prescription | Yes | |
| 002 | DEFENCATH | SOLUTION;N/A | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | HEPARIN SODIUM; TAUROLIDINE | 2023-11-15 | Prescription | Yes |