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Last Updated: September 19, 2020

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Details for New Drug Application (NDA): 208052

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NDA 208052 describes LURASIDONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Amneal Pharms Co, Emcure Pharms Ltd, Invagen Pharms, Lupin Ltd, Sun Pharm, Teva Pharms Usa, Torrent, and Zydus Pharms, and is included in nine NDAs. 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. Two suppliers are listed for this compound. Additional details are available on the lurasidone hydrochloride profile page.
Summary for 208052
Tradename:LURASIDONE HYDROCHLORIDE
Applicant:Zydus Pharms
Ingredient:lurasidone hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG
Approval Date:Mar 19, 2019TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength40MG
Approval Date:Mar 19, 2019TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength60MG
Approval Date:Mar 19, 2019TE:RLD:No

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