APPLICATION
ANDA078474
TYPE
ANDA
ORIGINAL APPROVAL
2010-08-06
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription
Products
RISPERIDONEPrescription
RISPERIDONE 3MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEPrescription
RISPERIDONE 4MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2025-01-22Labeling · Supplement 10 · standardAP
2022-09-28Labeling · Supplement 9 · standardAP
2020-10-20Labeling · Supplement 8 · standardAP
2020-10-20Labeling · Supplement 6 · standardAP
2020-10-20Labeling · Supplement 7 · standardAP
2020-10-20Labeling · Supplement 5 · standardAP
2014-11-28Labeling · Supplement 4 · standardAP
2012-10-29Labeling · Supplement 3 · standardAP
2012-07-27Labeling · Supplement 2 · standardAP
2012-02-21Labeling · Supplement 1AP
2010-08-06OriginalAP
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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