← FDA DRUG APPROVALS

FDA NDA · NDA213586

UZEDY

risperidone

Sponsor: TEVA

APPLICATION
NDA213586
TYPE
NDA
ORIGINAL APPROVAL
2023-04-28
LATEST ACTION
2025-10-10
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

UZEDY · ReferencePrescription
RISPERIDONE 200MG/0.56ML (200MG/0.56ML) · SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS
UZEDY · ReferencePrescription
RISPERIDONE 125MG/0.35ML (125MG/0.35ML) · SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS
UZEDY · ReferencePrescription
RISPERIDONE 75MG/0.21ML (75MG/0.21ML) · SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS
UZEDY · ReferencePrescription
RISPERIDONE 250MG/0.7ML (250MG/0.7ML) · SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS
UZEDY · ReferencePrescription
RISPERIDONE 150MG/0.42ML (150MG/0.42ML) · SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS
UZEDY · ReferencePrescription
RISPERIDONE 100MG/0.28ML (100MG/0.28ML) · SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS
UZEDY · ReferencePrescription
RISPERIDONE 50MG/0.14ML (50MG/0.14ML) · SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS

Approval history

2025-10-10Labeling · Supplement 9 · standard — Label ↗AP
2025-10-10Efficacy · Supplement 8 · standard — Label ↗AP
2025-01-22Labeling · Supplement 7 · standard — Label ↗AP
2023-11-01Labeling · Supplement 1 · standard — Letter ↗AP
2023-04-28Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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