APPLICATION
ANDA078740
TYPE
ANDA
ORIGINAL APPROVAL
2009-05-29
LATEST ACTION
2023-09-12
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
2023-09-12Labeling · Supplement 8 · standardAP
2023-09-12Labeling · Supplement 9 · standardAP
2020-10-21Labeling · Supplement 7 · standardAP
2020-10-21Labeling · Supplement 6 · standardAP
2012-12-31Labeling · Supplement 5 · standardAP
2011-12-08Labeling · Supplement 4AP
2011-03-15Labeling · Supplement 3AP
2010-02-04Labeling · Supplement 1AP
2009-05-29OriginalAP
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.
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