APPLICATION
ANDA214068
TYPE
ANDA
ORIGINAL APPROVAL
2023-12-05
LATEST ACTION
2023-12-05
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
RISPERIDONEPrescription
RISPERIDONE 12.5MG/VIAL · POWDER · INTRAMUSCULAR
Approval history
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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