FDA ANDA · ANDA078452
RISPERIDONE
Sponsor: AUROBINDO PHARMA LTD
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APPLICATION
ANDA078452
TYPE
ANDA
ORIGINAL APPROVAL
2009-09-04
LATEST ACTION
2026-10-14
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
RISPERIDONEPrescription
RISPERIDONE 1MG/ML · SOLUTION · ORAL
Approval history
2026-10-14Labeling · Supplement 17 · standardAP
2023-08-09Labeling · Supplement 12 · standardAP
2023-08-08Labeling · Supplement 16 · standardAP
2020-07-13Labeling · Supplement 8 · standardAP
2020-07-13Labeling · Supplement 6 · standardAP
2020-07-13Labeling · Supplement 11 · standardAP
2020-07-13Labeling · Supplement 9 · standardAP
2020-07-13Labeling · Supplement 7 · standardAP
2015-04-23Manufacturing (CMC) · Supplement 5 · unknownAP
2012-10-22Labeling · Supplement 4 · standardAP
2012-01-30Labeling · Supplement 3AP
2011-11-10Labeling · Supplement 2AP
2011-04-19Labeling · Supplement 1AP
2009-09-04OriginalAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →