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Orange Book product · Generic (ANDA)

CHLORPROMAZINE HYDROCHLORIDE

CHLORPROMAZINE HYDROCHLORIDE

Generic (ANDA)ANDA 216678TE AARX RUBICON RESEARCH

At a glance

Oct 10, 2025

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 10, 2025

    8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CHLORPROMAZINE HYDROCHLORIDE

Strength

30MG/ML

Dosage form

CONCENTRATE

Route

ORAL

TE code

AA

Application

ANDA 216678

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CHLORPROMAZINE 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.