Application 022387
- Type
- NDA
- Sponsor
- UNITED THERAP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TYVASO | TREPROSTINIL | SOLUTION;INHALATION | 0.6MG/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 66302-206 | TYVASO | treprostinil | United Therapeutics Corporation | NDA | Current |
| 66302-206 | TYVASO | treprostinil | United Therapeutics Corporation | NDA | Current |
| 66302-206 | TYVASO | treprostinil | United Therapeutics Corporation | NDA | Current |
| 66302-206 | TYVASO | treprostinil | United Therapeutics Corp. | NDA | Current |
| 66302-206 | TYVASO | treprostinil | United Therapeutics Corp. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85641 | SUPPL | 2026-04-07 |
| 71130 | SUPPL | 2022-05-23 |
| 71123 | SUPPL | 2022-05-23 |
| 69507 | SUPPL | 2021-12-07 |
| 66944 | SUPPL | 2021-04-01 |
| 66936 | SUPPL | 2021-04-01 |
| 50162 | SUPPL | 2017-10-24 |
| 50139 | SUPPL | 2017-10-23 |
| 17305 | SUPPL | 2016-06-13 |
| 7314 | SUPPL | 2016-06-08 |
| 38647 | SUPPL | 2014-05-28 |
| 7313 | SUPPL | 2014-05-22 |
| 29670 | SUPPL | 2013-05-02 |
| 38646 | SUPPL | 2013-05-01 |
| 29669 | SUPPL | 2011-02-14 |
| 38645 | SUPPL | 2011-02-09 |
| 22009 | ORIG | 2010-04-06 |
| 7312 | ORIG | 2009-08-06 |
| 44499 | ORIG | 2009-08-05 |
| 38644 | ORIG | 2009-07-30 |