Assyro AI

Orange Book product · Generic (ANDA)

ESMOLOL HYDROCHLORIDE

ESMOLOL HYDROCHLORIDE

Generic (ANDA)ANDA 076323TE APRX HIKMA

At a glance

Aug 10, 2004

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 10, 2004

    22 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ESMOLOL HYDROCHLORIDE

Strength

10MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 076323

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ESMOLOL 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.