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FDA NDA · NDA210655

PERSERIS KIT

Sponsor: INDIVIOR

APPLICATION
NDA210655
TYPE
NDA
ORIGINAL APPROVAL
2018-07-27
LATEST ACTION
2026-04-30
ROUTE
SUBCUTANEOUS
DOSAGE FORM
FOR SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

PERSERIS KIT · ReferenceDiscontinued
RISPERIDONE 120MG · FOR SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS
PERSERIS KIT · ReferenceDiscontinued
RISPERIDONE 90MG · FOR SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS

Approval history

2026-04-30Manufacturing (CMC) · Supplement 15AP
2025-01-24Labeling · Supplement 14 · standard — Label ↗AP
2022-12-15Efficacy · Supplement 10 · standard — Letter ↗AP
2022-08-29Manufacturing (CMC) · Supplement 11 · standard — Label ↗AP
2020-02-05Labeling · Supplement 4 · 901 required — Label ↗AP
2018-07-27Type 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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