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FDA NDA · NDA212849

RYKINDO EXTENDED-RELEASE MICROSPHERES

risperidone

Sponsor: SHANDONG LUYE

APPLICATION
NDA212849
TYPE
NDA
ORIGINAL APPROVAL
2023-01-13
LATEST ACTION
2026-01-16
ROUTE
INTRAMUSCULAR
DOSAGE FORM
FOR SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Discontinued, Prescription

Products

RYKINDO · ReferenceDiscontinued
RISPERIDONE 37.5MG · FOR SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
RYKINDO · ReferenceDiscontinued
RISPERIDONE 12.5MG · FOR SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
RYKINDO · ReferenceDiscontinued
RISPERIDONE 50MG · FOR SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
RYKINDO · ReferencePrescription
RISPERIDONE 25MG · FOR SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR

Approval history

2026-01-16Labeling · Supplement 3 · standard — Label ↗AP
2025-01-22Labeling · Supplement 1 · standard — Label ↗AP
2023-01-13Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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