APPLICATION
ANDA079059
TYPE
ANDA
ORIGINAL APPROVAL
2012-12-12
LATEST ACTION
2023-05-12
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
RISPERIDONEPrescription
RISPERIDONE 1MG/ML · SOLUTION · ORAL
Approval history
2023-05-12Labeling · Supplement 11 · standardAP
2023-05-12Labeling · Supplement 8 · standardAP
2023-05-12Labeling · Supplement 6 · standardAP
2023-05-12Labeling · Supplement 2 · standardAP
2023-05-12Labeling · Supplement 7 · standardAP
2023-05-12Labeling · Supplement 3 · standardAP
2023-05-12Labeling · Supplement 15 · standardAP
2012-12-12OriginalAP
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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