APPLICATION
ANDA211220
TYPE
ANDA
ORIGINAL APPROVAL
2025-09-02
LATEST ACTION
2025-09-02
ROUTE
INTRAMUSCULAR
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
RISPERIDONEPrescription
RISPERIDONE 50MG/VIAL · POWDER · INTRAMUSCULAR
RISPERIDONEPrescription
RISPERIDONE 25MG/VIAL · POWDER · INTRAMUSCULAR
RISPERIDONEPrescription
RISPERIDONE 37.5MG/VIAL · POWDER · INTRAMUSCULAR
Approval history
2025-09-02UNKNOWN · Original · standardAP
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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