APPLICATION
ANDA208045
TYPE
ANDA
ORIGINAL APPROVAL
2023-03-10
LATEST ACTION
2026-05-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LURASIDONE HYDROCHLORIDEPrescription
LURASIDONE HYDROCHLORIDE 80MG · TABLET · ORAL
LURASIDONE HYDROCHLORIDEPrescription
LURASIDONE HYDROCHLORIDE 40MG · TABLET · ORAL
LURASIDONE HYDROCHLORIDEPrescription
LURASIDONE HYDROCHLORIDE 120MG · TABLET · ORAL
LURASIDONE HYDROCHLORIDEPrescription
LURASIDONE HYDROCHLORIDE 60MG · TABLET · ORAL
LURASIDONE HYDROCHLORIDEPrescription
LURASIDONE HYDROCHLORIDE 20MG · TABLET · ORAL
Approval history
2026-05-15Labeling · Supplement 3 · standardAP
2023-03-10UNKNOWN · Original · 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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