Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 210793
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 None 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
09/27/2019 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
09/27/2019 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

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