← FDA DRUG APPROVALS

FDA ANDA · ANDA208002

LURASIDONE HYDROCHLORIDE

Sponsor: AMNEAL PHARMS CO

APPLICATION
ANDA208002
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-03
LATEST ACTION
2026-05-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LURASIDONE HYDROCHLORIDEDiscontinued
LURASIDONE HYDROCHLORIDE 120MG · TABLET · ORAL
LURASIDONE HYDROCHLORIDEDiscontinued
LURASIDONE HYDROCHLORIDE 60MG · TABLET · ORAL
LURASIDONE HYDROCHLORIDEDiscontinued
LURASIDONE HYDROCHLORIDE 20MG · TABLET · ORAL
LURASIDONE HYDROCHLORIDEDiscontinued
LURASIDONE HYDROCHLORIDE 80MG · TABLET · ORAL
LURASIDONE HYDROCHLORIDEDiscontinued
LURASIDONE HYDROCHLORIDE 40MG · TABLET · ORAL

Approval history

2026-05-19Labeling · Supplement 9 · standardAP
2024-12-03Labeling · Supplement 4 · standardAP
2024-12-03Labeling · Supplement 3 · standardAP
2019-01-03UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →