Assyro AI

Orange Book product · Generic (ANDA)

HALOPERIDOL

HALOPERIDOL LACTATE

Generic (ANDA)ANDA 218371TE AARX RUBICON RESEARCH

At a glance

Jan 31, 2024

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 31, 2024

    2 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HALOPERIDOL LACTATE

Strength

EQ 2MG BASE/ML

Dosage form

CONCENTRATE

Route

ORAL

TE code

AA

Application

ANDA 218371

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of HALOPERIDOL LACTATE

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.