Application 214520
- Type
- NDA
- Sponsor
- CORMEDIX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEFENCATH | HEPARIN SODIUM; TAUROLIDINE | SOLUTION;N/A | 3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML) | Yes | Yes |
| 002 | DEFENCATH | HEPARIN SODIUM; TAUROLIDINE | SOLUTION;N/A | 5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML) | Yes | Yes |