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FDA ANDA · ANDA208058

LURASIDONE HYDROCHLORIDE

Sponsor: HERITAGE PHARMA AVET

APPLICATION
ANDA208058
TYPE
ANDA
ORIGINAL APPROVAL
2019-09-04
LATEST ACTION
2026-05-14
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

2026-05-14Labeling · Supplement 10 · standardAP
2021-10-25Labeling · Supplement 1 · standardAP
2019-09-04UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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