Assyro AI

Orange Book product · Brand (NDA)

BREVIBLOC

ESMOLOL HYDROCHLORIDE

Brand (NDA)NDA 019386TE APRX BAXTER HLTHCARE
View ESMOLOL HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Feb 25, 2003

Approved

Brand (NDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 25, 2003

    23 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ESMOLOL HYDROCHLORIDE

Strength

10MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

NDA 019386

Product number

006

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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

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