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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 218174


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NDA 218174 describes LURASIDONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Annora Pharma, Aurobindo Pharma Ltd, Avet Lifesciences, Dr Reddys, Invagen Pharms, Lupin Ltd, Macleods Pharms Ltd, MSN, Slate Run Pharma, Sun Pharm, Teva Pharms Usa, Torrent, Watson Labs Teva, and Zydus Pharms, and is included in eighteen NDAs. It is available from twenty-six 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-seven suppliers are listed for this compound. Additional details are available on the lurasidone hydrochloride profile page.
Summary for 218174
Tradename:LURASIDONE HYDROCHLORIDE
Applicant:Annora Pharma
Ingredient:lurasidone hydrochloride
Patents:0
Pharmacology for NDA: 218174
Suppliers and Packaging for NDA: 218174
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 218174 ANDA Camber Pharmaceuticals, Inc. 31722-080 31722-080-05 500 TABLET, FILM COATED in 1 BOTTLE (31722-080-05)
LURASIDONE HYDROCHLORIDE lurasidone hydrochloride TABLET;ORAL 218174 ANDA Camber Pharmaceuticals, Inc. 31722-080 31722-080-30 30 TABLET, FILM COATED in 1 BOTTLE (31722-080-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Aug 21, 2024TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Aug 21, 2024TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Aug 21, 2024TE:ABRLD:No

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