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FDA NDA · NDA214835

RISVAN

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APPLICATION
NDA214835
TYPE
NDA
ORIGINAL APPROVAL
2024-03-29
LATEST ACTION
2025-01-22
ROUTE
INTRAMUSCULAR
DOSAGE FORM
FOR SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

RISVAN · ReferenceDiscontinued
RISPERIDONE 100MG · FOR SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
RISVAN · ReferenceDiscontinued
RISPERIDONE 75MG · FOR SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR

Approval history

2025-01-22Labeling · Supplement 4 · standard — Label ↗AP
2025-01-22Labeling · Supplement 1 · standard — Letter ↗AP
2024-03-29Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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