APPLICATION
ANDA077769
TYPE
ANDA
ORIGINAL APPROVAL
2008-10-16
LATEST ACTION
2024-07-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
RISPERIDONEDiscontinued
RISPERIDONE 4MG · TABLET · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 2MG · TABLET · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 0.5MG · TABLET · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 3MG · TABLET · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 1MG · TABLET · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 0.25MG · TABLET · ORAL
Approval history
2024-07-03Labeling · Supplement 5 · standardAP
2020-10-13Labeling · Supplement 4 · standardAP
2020-10-13Labeling · Supplement 3 · standardAP
2015-11-02Labeling · Supplement 1AP
2011-11-28Labeling · Supplement 2AP
2008-10-16OriginalAP
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.