Application 209279
- Type
- NDA
- Sponsor
- ACTELION PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRACLEER | BOSENTAN | TABLET, FOR SUSPENSION;ORAL | 32MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 66215-103 | Tracleer | bosentan | Actelion Pharmaceuticals US, Inc. | NDA | Current |
| 66215-103 | Tracleer | bosentan | Actelion Pharmaceuticals US, Inc. | NDA | Current |
| 66215-103 | Tracleer | bosentan | Actelion Pharmaceuticals US, Inc. | NDA | Current |
| 66215-103 | Tracleer | bosentan | Actelion Pharmaceuticals US, Inc. | NDA | Current |
| 66215-103 | Tracleer | bosentan | Actelion Pharmaceuticals US, Inc. | NDA | Current |
| 66215-103 | Tracleer | bosentan | Actelion Pharmaceuticals US, Inc. | NDA | Current |
| 66215-103 | Tracleer | bosentan | Actelion Pharmaceuticals US, Inc. | NDA | Current |
| 66215-103 | Tracleer | bosentan | Actelion Pharmaceuticals US, Inc. | NDA | Current |
| 66215-103 | Tracleer | bosentan | Actelion Pharmaceuticals US, Inc. | NDA | Current |
| 66215-232 | Tracleer | bosentan | Actelion Pharmaceuticals US, Inc. | NDA | Current |
| 66215-232 | Tracleer | bosentan | Actelion Pharmaceuticals US, Inc. | NDA | Current |
| 66215-232 | Tracleer | bosentan | Actelion Pharmaceuticals US, Inc. | NDA | Current |
| 66215-232 | Tracleer | bosentan | Actelion Pharmaceuticals US, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85269 | SUPPL | 2026-03-04 |
| 84135 | SUPPL | 2025-11-12 |
| 84136 | SUPPL | 2025-11-10 |
| 84084 | SUPPL | 2025-11-06 |
| 83013 | SUPPL | 2025-08-01 |
| 79654 | SUPPL | 2024-09-19 |
| 77458 | SUPPL | 2024-02-09 |
| 77430 | SUPPL | 2024-02-09 |
| 76401 | ORIG | 2023-11-06 |
| 72573 | SUPPL | 2022-11-07 |
| 72538 | SUPPL | 2022-11-02 |
| 70935 | SUPPL | 2022-05-03 |
| 58799 | SUPPL | 2019-05-20 |
| 58798 | SUPPL | 2019-05-20 |
| 58771 | SUPPL | 2019-05-17 |
| 58508 | SUPPL | 2019-05-01 |
| 58479 | SUPPL | 2019-04-30 |
| 56183 | SUPPL | 2018-10-30 |
| 56110 | SUPPL | 2018-10-26 |
| 55866 | ORIG | 2018-10-10 |
| 55865 | SUPPL | 2018-10-10 |
| 49667 | ORIG | 2018-06-25 |
| 50142 | SUPPL | 2017-12-29 |