APPLICATION
ANDA077543
TYPE
ANDA
ORIGINAL APPROVAL
2011-05-18
LATEST ACTION
2024-03-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
RISPERIDONEPrescription
RISPERIDONE 4MG · TABLET · ORAL
RISPERIDONEPrescription
RISPERIDONE 2MG · TABLET · ORAL
RISPERIDONEPrescription
RISPERIDONE 0.5MG · TABLET · ORAL
RISPERIDONEPrescription
RISPERIDONE 3MG · TABLET · ORAL
RISPERIDONEPrescription
RISPERIDONE 1MG · TABLET · ORAL
RISPERIDONEPrescription
RISPERIDONE 0.25MG · TABLET · ORAL
Approval history
2024-03-05Labeling · Supplement 6 · standardAP
2024-03-05Labeling · Supplement 5 · standardAP
2015-10-22Labeling · Supplement 4 · standardAP
2012-11-27Labeling · Supplement 3 · standardAP
2012-08-24Labeling · Supplement 2AP
2011-11-15Labeling · Supplement 1AP
2011-05-18OriginalAP
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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