Assyro AI

Orange Book product · Generic (ANDA)

ESOMEPRAZOLE MAGNESIUM

ESOMEPRAZOLE MAGNESIUM

Generic (ANDA)ANDA 213859TE ABRX GUANGZHOU NOVAKEN

At a glance

Nov 18, 2020

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 18, 2020

    5 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ESOMEPRAZOLE MAGNESIUM

Strength

EQ 20MG BASE

Dosage form

CAPSULE, DELAYED REL PELLETS

Route

ORAL

TE code

AB

Application

ANDA 213859

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ESOMEPRAZOLE MAGNESIUM

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.