Assyro AI

Orange Book product · Generic (ANDA)

ESOMEPRAZOLE MAGNESIUM

ESOMEPRAZOLE MAGNESIUM

Generic (ANDA)ANDA 216349OTC GRAVITI PHARMS
View ESOMEPRAZOLE MAGNESIUM familyOpen on FDA Orange Book

At a glance

Jun 24, 2022

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 24, 2022

    4 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ESOMEPRAZOLE MAGNESIUM

Strength

EQ 20MG BASE

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 216349

Product number

001

Marketing status

OTC

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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