Application 022081
- Type
- NDA
- Sponsor
- GILEAD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LETAIRIS | AMBRISENTAN | TABLET;ORAL | 5MG | Yes | No |
| 002 | LETAIRIS | AMBRISENTAN | TABLET;ORAL | 10MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 61958-0801 | Letairis | AMBRISENTAN | Gilead Sciences, Inc | NDA | Current |
| 61958-0801 | Letairis | AMBRISENTAN | Gilead Sciences, Inc | NDA | Current |
| 61958-0801 | Letairis | AMBRISENTAN | Gilead Sciences, Inc | NDA | Current |
| 61958-0802 | Letairis | AMBRISENTAN | Gilead Sciences, Inc | NDA | Current |
| 61958-0802 | Letairis | AMBRISENTAN | Gilead Sciences, Inc | NDA | Current |
| 61958-0802 | Letairis | AMBRISENTAN | Gilead Sciences, Inc | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 81888 | SUPPL | 2025-04-08 |
| 81831 | SUPPL | 2025-04-07 |
| 79448 | SUPPL | 2024-08-20 |
| 76409 | ORIG | 2023-11-06 |
| 67748 | SUPPL | 2021-06-09 |
| 65715 | SUPPL | 2020-12-23 |
| 60998 | SUPPL | 2019-11-20 |
| 59843 | SUPPL | 2019-08-27 |
| 59842 | SUPPL | 2019-08-26 |
| 59841 | SUPPL | 2019-08-26 |
| 58173 | APPL | 2019-04-01 |
| 58154 | SUPPL | 2019-03-29 |
| 56659 | SUPPL | 2018-12-07 |
| 56614 | SUPPL | 2018-12-03 |
| 49890 | SUPPL | 2017-09-29 |
| 49073 | SUPPL | 2017-07-25 |
| 46218 | SUPPL | 2016-12-19 |
| 16915 | SUPPL | 2015-10-08 |
| 6848 | SUPPL | 2015-10-06 |
| 6847 | SUPPL | 2014-10-30 |
| 21933 | SUPPL | 2014-08-01 |
| 38205 | SUPPL | 2014-05-06 |
| 29220 | SUPPL | 2014-05-06 |
| 6846 | SUPPL | 2014-02-04 |
| 16914 | SUPPL | 2014-02-03 |
| 6845 | SUPPL | 2013-08-22 |
| 38203 | SUPPL | 2013-08-21 |
| 29219 | SUPPL | 2012-10-23 |
| 38204 | SUPPL | 2012-10-22 |
| 16913 | SUPPL | 2012-02-17 |
| 6841 | SUPPL | 2012-02-17 |
| 6844 | SUPPL | 2011-07-21 |
| 38202 | SUPPL | 2011-07-20 |
| 6843 | SUPPL | 2011-03-08 |
| 38201 | SUPPL | 2011-03-07 |
| 38200 | SUPPL | 2010-10-25 |
| 29218 | SUPPL | 2010-10-20 |
| 24016 | ORIG | 2010-09-01 |
| 6842 | SUPPL | 2010-08-26 |
| 29216 | SUPPL | 2009-11-24 |
| 23353 | ORIG | 2009-09-02 |
| 16911 | SUPPL | 2009-08-13 |
| 16912 | SUPPL | 2009-07-09 |
| 29217 | SUPPL | 2009-07-08 |
| 38199 | SUPPL | 2009-06-10 |
| 29215 | SUPPL | 2009-06-10 |
| 38198 | SUPPL | 2008-11-07 |
| 29214 | SUPPL | 2008-10-14 |
| 16910 | SUPPL | 2008-02-25 |
| 29213 | SUPPL | 2008-02-19 |
| 6840 | SUPPL | 2007-12-03 |
| 21932 | ORIG | 2007-08-21 |
| 6839 | ORIG | 2007-07-05 |
| 38197 | ORIG | 2007-06-27 |