Assyro AI

Orange Book product · Generic (ANDA)

HALOPERIDOL

HALOPERIDOL LACTATE

Generic (ANDA)ANDA 204849DISCN EPIC PHARMA LLC

At a glance

Sep 06, 2017

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 06, 2017

    8 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HALOPERIDOL LACTATE

Strength

EQ 5MG BASE/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 204849

Product number

001

Marketing status

DISCN

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.