Assyro AI

Orange Book product · Generic (ANDA)

HALOPERIDOL DECANOATE

HALOPERIDOL DECANOATE

Generic (ANDA)ANDA 076463DISCN SANDOZ

At a glance

Jun 24, 2005

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 24, 2005

    21 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HALOPERIDOL DECANOATE

Strength

EQ 50MG BASE/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 076463

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 DECANOATE

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.