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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 210388

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NDA 210388 describes LURASIDONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Annora Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys, Heritage Pharma Avet, Invagen Pharms, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, MSN, Sun Pharm, Teva Pharms Usa, Torrent, Watson Labs Teva, and Zydus Pharms, and is included in nineteen NDAs. It is available from twenty-nine suppliers. Additional details are available on the LURASIDONE HYDROCHLORIDE profile page.

The generic ingredient in LURASIDONE HYDROCHLORIDE is lurasidone hydrochloride. There are twenty-six drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the lurasidone hydrochloride profile page.

Summary for 210388

Tradename:	LURASIDONE HYDROCHLORIDE
Applicant:	Jubilant Generics
Ingredient:	lurasidone hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 210388

Adrenergic alpha-2 Receptor Antagonists
Antipsychotic Agents
Dopamine D2 Receptor Antagonists
Serotonin 5-HT2 Receptor Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Dec 6, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Dec 6, 2024	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	60MG
Approval Date:	Dec 6, 2024	TE:	AB	RLD:	No

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