APPLICATION
ANDA208031
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-03
LATEST ACTION
2025-05-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LURASIDONE HYDROCHLORIDEPrescription
LURASIDONE HYDROCHLORIDE 120MG · TABLET · ORAL
LURASIDONE HYDROCHLORIDEPrescription
LURASIDONE HYDROCHLORIDE 60MG · TABLET · ORAL
LURASIDONE HYDROCHLORIDEPrescription
LURASIDONE HYDROCHLORIDE 20MG · TABLET · ORAL
LURASIDONE HYDROCHLORIDEPrescription
LURASIDONE HYDROCHLORIDE 80MG · TABLET · ORAL
LURASIDONE HYDROCHLORIDEPrescription
LURASIDONE HYDROCHLORIDE 40MG · TABLET · ORAL
Approval history
2025-05-08Manufacturing (CMC) · Supplement 5 · unknownAP
2025-04-15Labeling · Supplement 7 · standardAP
2022-10-06Labeling · Supplement 1 · standardAP
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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