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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 212244


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NDA 212244 describes LURASIDONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Aurobindo Pharma Ltd, Avet Lifesciences, Dr Reddys, Invagen Pharms, Lupin Ltd, Macleods Pharms Ltd, MSN, Piramal Hlthcare Uk, Sun Pharm, Teva Pharms Usa, Torrent, Watson Labs Teva, and Zydus Pharms, and is included in seventeen NDAs. It is available from twenty-three 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. Twenty-four suppliers are listed for this compound. Additional details are available on the lurasidone hydrochloride profile page.
Summary for 212244
Tradename:LURASIDONE HYDROCHLORIDE
Applicant:Alkem Labs Ltd
Ingredient:lurasidone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 212244
Suppliers and Packaging for NDA: 212244
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 212244 ANDA Major Pharmaceuticals 0904-7355 0904-7355-04 30 BLISTER PACK in 1 CARTON (0904-7355-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK
LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 212244 ANDA Major Pharmaceuticals 0904-7356 0904-7356-61 100 BLISTER PACK in 1 CARTON (0904-7356-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Dec 13, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Dec 13, 2022TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Dec 13, 2022TE:ABRLD:No

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