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FDA NDA · NDA210793

NUPLAZID

pimavanserin tartrate

Sponsor: ACADIA PHARMS INC

APPLICATION
NDA210793
TYPE
NDA
ORIGINAL APPROVAL
2018-06-28
LATEST ACTION
2026-04-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

NUPLAZID · ReferencePrescription
PIMAVANSERIN TARTRATE EQ 34MG BASE · CAPSULE · ORAL

Approval history

2026-04-27Efficacy · Supplement 14 · priority — Letter ↗AP
2025-01-22Labeling · Supplement 12 · standard — Label ↗AP
2023-09-15Efficacy · Supplement 9 · standard — Letter ↗AP
2020-11-23Labeling · Supplement 7 · standard — Letter ↗AP
2019-09-27Labeling · Supplement 3 · standard — Letter ↗AP
2019-05-10Labeling · Supplement 2 · standard — Letter ↗AP
2019-03-04Labeling · Supplement 1 · standard — Label ↗AP
2018-06-28Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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