Application 208276
- Type
- NDA
- Sponsor
- UNITED THERAP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | REMODULIN | TREPROSTINIL | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 20MG/20ML (1MG/ML) | No | No |
| 002 | REMODULIN | TREPROSTINIL | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 50MG/20ML (2.5MG/ML) | No | No |
| 003 | REMODULIN | TREPROSTINIL | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 100MG/20ML (5MG/ML) | No | No |
| 004 | REMODULIN | TREPROSTINIL | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 200MG/20ML (10MG/ML) | No | No |