APPLICATION
ANDA077494
TYPE
ANDA
ORIGINAL APPROVAL
2009-04-30
LATEST ACTION
2026-06-08
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription
Products
RISPERIDONEPrescription
RISPERIDONE 1MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEPrescription
RISPERIDONE 3MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEPrescription
RISPERIDONE 1MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEPrescription
RISPERIDONE 0.25MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEPrescription
RISPERIDONE 4MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEPrescription
RISPERIDONE 2MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEPrescription
RISPERIDONE 0.5MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2026-06-08Labeling · Supplement 27 · standardAP
2022-08-31Labeling · Supplement 18 · standardAP
2022-08-31Labeling · Supplement 20 · standardAP
2019-12-09Labeling · Supplement 15 · standardAP
2019-12-09Labeling · Supplement 16 · standardAP
2015-09-22Labeling · Supplement 13 · standardAP
2013-08-30Labeling · Supplement 11 · standardAP
2012-04-10Labeling · Supplement 10AP
2012-02-21Labeling · Supplement 9AP
2011-05-27Labeling · Supplement 8AP
2010-12-29Labeling · Supplement 7AP
2009-10-26Manufacturing (CMC) · Supplement 4AP
2009-10-19Labeling · Supplement 3AP
2009-04-30OriginalAP
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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