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FDA ANDA · ANDA208047

LURASIDONE HYDROCHLORIDE

Sponsor: DR REDDYS

APPLICATION
ANDA208047
TYPE
ANDA
ORIGINAL APPROVAL
2021-08-24
LATEST ACTION
2026-06-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

2026-06-01Labeling · Supplement 4 · standardAP
2026-06-01Labeling · Supplement 3 · standardAP
2021-08-24UNKNOWN · Original · standardAP
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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