APPLICATION
ANDA078040
TYPE
ANDA
ORIGINAL APPROVAL
2008-10-16
LATEST ACTION
2025-06-13
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
2025-06-13Labeling · Supplement 30 · standardAP
2024-07-14Labeling · Supplement 28 · standardAP
2024-07-14Labeling · Supplement 29 · standardAP
2020-08-28Labeling · Supplement 27 · standardAP
2019-10-28Labeling · Supplement 18 · standardAP
2019-10-28Labeling · Supplement 24 · standardAP
2019-10-28Labeling · Supplement 17 · standardAP
2019-10-28Labeling · Supplement 23 · standardAP
2014-09-25Labeling · Supplement 14 · standardAP
2012-12-12Labeling · Supplement 11 · standardAP
2012-01-03Labeling · Supplement 9AP
2012-01-03Labeling · Supplement 10AP
2011-07-11Labeling · Supplement 8AP
2011-06-08Labeling · Supplement 4AP
2010-12-29Labeling · Supplement 3AP
2010-01-12Labeling · Supplement 2AP
2008-10-16OriginalAP
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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