APPLICATION
ANDA078116
TYPE
ANDA
ORIGINAL APPROVAL
2009-12-22
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription
Products
RISPERIDONEPrescription
RISPERIDONE 4MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEPrescription
RISPERIDONE 2MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEPrescription
RISPERIDONE 0.5MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEPrescription
RISPERIDONE 3MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEPrescription
RISPERIDONE 1MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2025-01-22Labeling · Supplement 17 · standardAP
2022-09-01Labeling · Supplement 12 · standardAP
2022-09-01Labeling · Supplement 15 · standardAP
2022-09-01Labeling · Supplement 13 · standardAP
2022-09-01Labeling · Supplement 16 · standardAP
2022-09-01Labeling · Supplement 14 · standardAP
2014-11-28Labeling · Supplement 11 · standardAP
2013-04-10Labeling · Supplement 10 · standardAP
2012-04-30Labeling · Supplement 4AP
2012-03-01Labeling · Supplement 2AP
2012-02-21Labeling · Supplement 3AP
2011-06-10Labeling · Supplement 1AP
2009-12-22OriginalAP
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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