APPLICATION
ANDA077328
TYPE
ANDA
ORIGINAL APPROVAL
2009-02-24
LATEST ACTION
2025-01-24
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
2025-01-24Labeling · Supplement 13 · standardAP
2025-01-23Labeling · Supplement 11 · standardAP
2025-01-23Labeling · Supplement 12 · standardAP
2012-12-20Labeling · Supplement 10 · standardAP
2012-07-25Labeling · Supplement 8AP
2012-04-30Labeling · Supplement 9AP
2011-10-26Labeling · Supplement 7AP
2011-08-09Labeling · Supplement 6AP
2011-05-27Labeling · Supplement 5AP
2010-12-29Labeling · Supplement 4AP
2009-11-30Manufacturing (CMC) · Supplement 3AP
2009-10-05Manufacturing (CMC) · Supplement 2AP
2009-08-24Labeling · Supplement 1AP
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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