APPLICATION
ANDA201003
TYPE
ANDA
ORIGINAL APPROVAL
2011-08-24
LATEST ACTION
2024-06-12
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
2024-06-12Labeling · Supplement 28 · standardAP
2024-06-12Labeling · Supplement 45 · standardAP
2024-06-12Labeling · Supplement 19 · standardAP
2019-11-12Labeling · Supplement 16 · standardAP
2019-11-12Labeling · Supplement 14 · standardAP
2019-11-12Labeling · Supplement 10 · standardAP
2017-09-08Manufacturing (CMC) · Supplement 8 · unknownAP
2017-02-01Labeling · Supplement 7 · standardAP
2015-08-27Labeling · Supplement 3 · standardAP
2015-08-27Labeling · Supplement 4 · standardAP
2015-03-17Manufacturing (CMC) · Supplement 6AP
2012-12-31Labeling · Supplement 2 · standardAP
2012-07-25Labeling · Supplement 1AP
2011-08-24Not Applicable · OriginalAP
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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