APPLICATION
ANDA076908
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-12
LATEST ACTION
2024-06-12
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued
Products
RISPERIDONEDiscontinued
RISPERIDONE 2MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 0.5MG · TABLET, ORALLY DISINTEGRATING · ORAL
RISPERIDONEDiscontinued
RISPERIDONE 1MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2024-06-12Labeling · Supplement 4 · standardAP
2024-06-12Labeling · Supplement 2 · standardAP
2024-06-12Labeling · Supplement 3 · standardAP
2024-06-12Labeling · Supplement 1 · standardAP
2012-03-12OriginalAP
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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