Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 210793
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 34MG BASE | CAPSULE;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 |
---|---|---|---|---|---|---|---|
06/28/2018 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210793_207318s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210793Orig1s000,207318Orig1s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210793Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/15/2023 | SUPPL-9 | 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-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207318s010,210793s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207318Orig1s010, 210793Orig1s007ltr.pdf | |
09/27/2019 | SUPPL-3 | Labeling-Patient 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,%20210793Orig1s003ltr.pdf | |
05/10/2019 | SUPPL-2 | Labeling |
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-1 | 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 |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/15/2023 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210793s009,207318s012lbl.pdf | |
11/23/2020 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207318s010,210793s007lbl.pdf | |
09/27/2019 | SUPPL-3 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207318s009,210793s003lbl.pdf | |
05/10/2019 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207318s007,210793s002lbl.pdf | |
03/04/2019 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207318s006,210793s001lbl.pdf | |
06/28/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210793_207318s003lbl.pdf |
NUPLAZID
CAPSULE;ORAL; EQ 34MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NUPLAZID | PIMAVANSERIN TARTRATE | EQ 34MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 210793 | ACADIA PHARMS INC |