APPLICATION
ANDA079088
TYPE
ANDA
ORIGINAL APPROVAL
2008-10-30
LATEST ACTION
2025-06-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
RISPERIDONEPrescription
RISPERIDONE 3MG · TABLET · ORAL
RISPERIDONEPrescription
RISPERIDONE 1MG · TABLET · ORAL
RISPERIDONEPrescription
RISPERIDONE 0.25MG · TABLET · ORAL
RISPERIDONEPrescription
RISPERIDONE 4MG · TABLET · ORAL
RISPERIDONEPrescription
RISPERIDONE 2MG · TABLET · ORAL
RISPERIDONEPrescription
RISPERIDONE 0.5MG · TABLET · ORAL
Approval history
2025-06-17Labeling · Supplement 25 · standardAP
2024-06-12Labeling · Supplement 17 · standardAP
2024-06-12Labeling · Supplement 21 · standardAP
2024-06-12Labeling · Supplement 18 · standardAP
2024-06-12Labeling · Supplement 24 · standardAP
2024-06-12Labeling · Supplement 22 · standardAP
2024-06-12Labeling · Supplement 20 · standardAP
2014-09-26Labeling · Supplement 15 · standardAP
2012-11-30Labeling · Supplement 13 · standardAP
2012-01-03Labeling · Supplement 11AP
2012-01-03Labeling · Supplement 12AP
2011-08-26Labeling · Supplement 10AP
2011-08-16Labeling · Supplement 8AP
2011-05-27Labeling · Supplement 6AP
2010-12-29Labeling · Supplement 5AP
2010-06-29Labeling · Supplement 4AP
2009-12-15Labeling · Supplement 2AP
2009-12-02Manufacturing (CMC) · Supplement 3AP
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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