APPLICATION
ANDA076879
TYPE
ANDA
ORIGINAL APPROVAL
2008-10-24
LATEST ACTION
2024-08-27
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
2024-08-27Labeling · Supplement 9 · standardAP
2024-08-27Labeling · Supplement 10 · standardAP
2012-01-05Labeling · Supplement 8AP
2012-01-05Labeling · Supplement 7AP
2011-10-26Labeling · Supplement 6AP
2011-08-03Labeling · Supplement 5AP
2011-05-27Labeling · Supplement 4AP
2010-12-29Labeling · Supplement 3AP
2010-02-02Labeling · Supplement 1AP
2008-10-24OriginalAP
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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