FDA ANDA · ANDA078464
RISPERIDONE
Sponsor: SUN PHARM INDS LTD
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APPLICATION
ANDA078464
TYPE
ANDA
ORIGINAL APPROVAL
2013-04-08
LATEST ACTION
2026-10-20
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued
Products
RISPERIDONEDiscontinued
RISPERIDONE 3MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 1MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 4MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 2MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 0.5MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2026-10-20Labeling · Supplement 14 · standardAP
2016-01-05Labeling · Supplement 5 · standardAP
2013-04-08OriginalAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →