APPLICATION
ANDA090347
TYPE
ANDA
ORIGINAL APPROVAL
2011-02-07
LATEST ACTION
2025-02-13
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
RISPERIDONEDiscontinued
RISPERIDONE 1MG/ML · SOLUTION · ORAL
Approval history
2025-02-13Labeling · Supplement 5 · standardAP
2025-02-13Labeling · Supplement 4 · standardAP
2012-03-01Labeling · Supplement 2AP
2011-11-10Labeling · Supplement 1AP
2011-02-07OriginalAP
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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