Application 022526
- Type
- NDA
- Sponsor
- SPROUT PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ADDYI | FLIBANSERIN | TABLET;ORAL | 100MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 58604-214 | ADDYI | flibanserin | Sprout Pharmaceuticals, Inc. | NDA | Current |
| 58604-214 | ADDYI | flibanserin | Sprout Pharmaceuticals, Inc. | NDA | Current |
| 58604-214 | ADDYI | flibanserin | Sprout Pharmaceuticals, Inc. | NDA | Current |
| 58604-214 | ADDYI | flibanserin | Sprout Pharmaceuticals, Inc. | NDA | Current |
| 58604-214 | ADDYI | flibanserin | Sprout Pharmaceuticals, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84453 | SUPPL | 2025-12-18 |
| 84411 | SUPPL | 2025-12-15 |
| 80900 | SUPPL | 2025-02-04 |
| 80163 | SUPPL | 2024-11-05 |
| 80162 | SUPPL | 2024-11-05 |
| 68831 | SUPPL | 2021-10-01 |
| 68810 | SUPPL | 2021-09-30 |
| 60534 | SUPPL | 2019-10-11 |
| 60524 | SUPPL | 2019-10-10 |
| 60523 | SUPPL | 2019-10-10 |
| 60522 | SUPPL | 2019-10-10 |
| 60513 | SUPPL | 2019-10-10 |
| 58293 | SUPPL | 2019-04-11 |
| 58291 | ORIG | 2019-04-11 |
| 58204 | SUPPL | 2019-04-04 |
| 48778 | SUPPL | 2017-06-20 |
| 29831 | SUPPL | 2016-04-11 |
| 42551 | ORIG | 2015-10-01 |
| 24333 | ORIG | 2015-08-24 |
| 44508 | ORIG | 2015-08-18 |
| 38813 | ORIG | 2015-08-18 |