NDA 208276, held by United Therap. Treprostinil.
As of Nov 13, 2026, NDA 208276 (Remodulin), held by United Therap, was first approved by FDA on Jul 30, 2018, with 0 approved supplements and 2 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 30, 2018 | Original applicationNew dosage form · Standard review | Approved |
| Jun 2, 2017 | Implantable SystemClinical | Approved |
| Oct 7, 2016 | The Remodulin (treprostinil) Implantable SystemClinical, Product Quality | Approved |
| Remodulin20MG/20ML (1MG/ML) · solution;intravenous, subcutaneous | Treprostinil | Discontinued |
| Remodulin50MG/20ML (2.5MG/ML) · solution;intravenous, subcutaneous | Treprostinil | Discontinued |
| Remodulin100MG/20ML (5MG/ML) · solution;intravenous, subcutaneous | Treprostinil | Discontinued |
| Remodulin200MG/20ML (10MG/ML) · solution;intravenous, subcutaneous | Treprostinil | Discontinued |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
