APPLICATION
ANDA077493
TYPE
ANDA
ORIGINAL APPROVAL
2011-11-29
LATEST ACTION
2024-03-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
RISPERIDONEPrescription
RISPERIDONE 0.25MG · TABLET · ORAL
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
Approval history
2024-03-05Labeling · Supplement 10 · standardAP
2022-10-25Labeling · Supplement 8 · standardAP
2020-11-17Labeling · Supplement 6 · standardAP
2020-11-17Labeling · Supplement 4 · standardAP
2017-01-26Labeling · Supplement 3 · standardAP
2017-01-26Labeling · Supplement 2 · standardAP
2011-11-29OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.