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Orange Book product · Generic (ANDA)

ESOMEPRAZOLE MAGNESIUM

ESOMEPRAZOLE MAGNESIUM

Generic (ANDA)ANDA 218948TE ABRX AUROBINDO PHARMA LTD
View ESOMEPRAZOLE MAGNESIUM familyOpen on FDA Orange Book

At a glance

Apr 15, 2025

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 15, 2025

    1 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ESOMEPRAZOLE MAGNESIUM

Strength

EQ 5MG BASE/PACKET

Dosage form

FOR SUSPENSION, DELAYED RELEASE

Route

ORAL

TE code

AB

Application

ANDA 218948

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.

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