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Orange Book product · Generic (ANDA)

LURASIDONE HYDROCHLORIDE

LURASIDONE HYDROCHLORIDE

Generic (ANDA)ANDA 208045TE ABRX AUROBINDO PHARMA LTD
View LURASIDONE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Mar 10, 2023

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 10, 2023

    3 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LURASIDONE HYDROCHLORIDE

Strength

20MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 208045

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of LURASIDONE HYDROCHLORIDE

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

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