Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 207318
Company: ACADIA PHARMS INC
Company: ACADIA PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NUPLAZID | PIMAVANSERIN TARTRATE | EQ 17MG BASE | TABLET;ORAL | Discontinued | None | Yes | No |
NUPLAZID | PIMAVANSERIN TARTRATE | EQ 10MG BASE | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/29/2016 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207318lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207318Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207318Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207318Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/15/2023 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210793s009,207318s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207318Orig1s012;210793Orig1s009ltr.pdf | |
11/23/2020 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207318s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207318Orig1s010, 210793Orig1s007ltr.pdf | |
09/27/2019 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207318s009,210793s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207318Orig1s009, 210793Orig1s003ltr.pdf | |
05/10/2019 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207318s007,210793s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207318Orig1s007, 210793Orig1s002ltr.pdf | |
03/04/2019 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207318s006,210793s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207318Orig1s006,210793Orig1s001ltr.pdf | |
06/06/2018 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207318s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207318Orig1s005ltr.pdf | |
03/04/2018 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207318s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207318Orig1s002s004ltr.pdf | |
06/28/2018 | SUPPL-3 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210793_207318s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210793Orig1s000,207318Orig1s003ltr.pdf | |
03/04/2018 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207318s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207318Orig1s002s004ltr.pdf | |
10/17/2017 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207318s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207318Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/15/2023 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210793s009,207318s012lbl.pdf | |
11/23/2020 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207318s010lbl.pdf | |
09/27/2019 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207318s009,210793s003lbl.pdf | |
05/10/2019 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207318s007,210793s002lbl.pdf | |
03/04/2019 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207318s006,210793s001lbl.pdf | |
06/28/2018 | SUPPL-3 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210793_207318s003lbl.pdf | |
06/06/2018 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207318s005lbl.pdf | |
03/04/2018 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207318s002s004lbl.pdf | |
03/04/2018 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207318s002s004lbl.pdf | |
10/17/2017 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207318s001lbl.pdf | |
04/29/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207318lbl.pdf |
NUPLAZID
TABLET;ORAL; EQ 10MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NUPLAZID | PIMAVANSERIN TARTRATE | EQ 10MG BASE | TABLET;ORAL | Prescription | Yes | AB | 207318 | ACADIA PHARMS INC |