Application 207318
- Type
- NDA
- Sponsor
- ACADIA PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NUPLAZID | PIMAVANSERIN TARTRATE | TABLET;ORAL | EQ 17MG BASE | Yes | No |
| 002 | NUPLAZID | PIMAVANSERIN TARTRATE | TABLET;ORAL | EQ 10MG BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63090-100 | NUPLAZID | pimavanserin tartrate | ACADIA Pharmaceuticals In | NDA | Current |
| 63090-100 | NUPLAZID | pimavanserin tartrate | ACADIA Pharmaceuticals Inc | NDA | Current |
| 63090-100 | NUPLAZID | pimavanserin tartrate | ACADIA Pharmaceuticals Inc | NDA | Current |
| 63090-100 | NUPLAZID | pimavanserin tartrate | ACADIA Pharmaceuticals Inc | NDA | Current |
| 63090-100 | NUPLAZID | pimavanserin tartrate | Acadia Pharmaceuticals Inc. | NDA | Current |
| 63090-100 | NUPLAZID | pimavanserin tartrate | ACADIA Pharmaceuticals Inc | NDA | Current |
| 63090-100 | NUPLAZID | pimavanserin tartrate | Acadia Pharmaceuticals Inc. | NDA | Current |
| 63090-100 | NUPLAZID | pimavanserin tartrate | ACADIA Pharmaceuticals Inc | NDA | Current |
| 63090-170 | NUPLAZID | pimavanserin tartrate | ACADIA Pharmaceuticals In | NDA | Current |
| 63090-170 | NUPLAZID | pimavanserin tartrate | ACADIA Pharmaceuticals Inc | NDA | Current |
| 63090-170 | NUPLAZID | pimavanserin tartrate | ACADIA Pharmaceuticals Inc | NDA | Current |
| 63090-170 | NUPLAZID | pimavanserin tartrate | ACADIA Pharmaceuticals Inc | NDA | Current |
| 63090-170 | NUPLAZID | pimavanserin tartrate | ACADIA Pharmaceuticals Inc | NDA | Current |
| 63090-170 | NUPLAZID | pimavanserin tartrate | ACADIA Pharmaceuticals Inc | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85839 | SUPPL | 2026-05-05 |
| 85785 | SUPPL | 2026-05-01 |
| 80931 | SUPPL | 2026-05-01 |
| 81148 | SUPPL | 2025-02-07 |
| 75507 | SUPPL | 2023-09-18 |
| 75504 | SUPPL | 2023-09-18 |
| 65342 | SUPPL | 2020-11-25 |
| 65321 | SUPPL | 2020-11-25 |
| 60201 | SUPPL | 2019-10-02 |
| 60169 | SUPPL | 2019-10-01 |
| 58675 | SUPPL | 2019-05-14 |
| 58654 | SUPPL | 2019-05-13 |
| 57917 | SUPPL | 2019-03-07 |
| 57889 | SUPPL | 2019-03-05 |
| 55384 | SUPPL | 2018-09-05 |
| 54826 | SUPPL | 2018-07-06 |
| 54552 | SUPPL | 2018-06-14 |
| 54486 | SUPPL | 2018-06-08 |
| 53015 | SUPPL | 2018-03-15 |
| 53014 | SUPPL | 2018-03-15 |
| 52824 | SUPPL | 2018-03-06 |
| 52823 | SUPPL | 2018-03-06 |
| 50152 | SUPPL | 2017-10-23 |
| 50106 | SUPPL | 2017-10-19 |
| 44957 | ORIG | 2016-06-02 |
| 23034 | ORIG | 2016-06-02 |
| 40585 | ORIG | 2016-05-02 |
| 10614 | ORIG | 2016-05-02 |