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Orange Book product · Generic (ANDA)

CARIPRAZINE HYDROCHLORIDE

CARIPRAZINE HYDROCHLORIDE

Generic (ANDA)ANDA 213982DISCN AUROBINDO PHARMA LTD

At a glance

Dec 16, 2025

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 16, 2025

    6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CARIPRAZINE HYDROCHLORIDE

Strength

EQ 1.5MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

ANDA 213982

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CARIPRAZINE 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.