FdaApplication
NDA 214520
Identifiers
- fda_app_no: NDA214520
Properties
| Property | Value |
|---|---|
| applicant_name | CORMEDIX INC |
| application_type | NDA |
| approval_date | 2023-11-15 |
Revenue by product
DEFENCATH
| Period | Revenue |
|---|---|
| Q4 2025 | $91.2M |
| Q3 2025 | $88.8M |
| Q4 2024 | $31.2M |
| Q3 2024 | $11.5M |
Revenue as this company reported it for this product. A combination product's amount is stated once, for the product, and never divided across its ingredients. A fourth quarter is the reported full year less nine months, since no filing states one.
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DEFENCATH | HEPARIN SODIUM; TAUROLIDINE | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | SOLUTION;N/A |
| DEFENCATH | HEPARIN SODIUM; TAUROLIDINE | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | SOLUTION;N/A |
2 products