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Orange Book product · Generic (ANDA)

LURASIDONE HYDROCHLORIDE

LURASIDONE HYDROCHLORIDE

Generic (ANDA)ANDA 218174TE ABRX ANNORA PHARMA

At a glance

Aug 21, 2024

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 21, 2024

    1 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LURASIDONE HYDROCHLORIDE

Strength

20MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 218174

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.