Orange Book product · Brand (NDA)

NEXIUM 24HR

ESOMEPRAZOLE MAGNESIUM

Brand (NDA)NDA 207920OTC ASTRAZENECA LP

View ESOMEPRAZOLE MAGNESIUM family Open on FDA Orange Book

At a glance

Nov 23, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Nov 23, 2015
10 yr 9 mo ago
Today

Pharmaceutical detail

Active ingredient

ESOMEPRAZOLE MAGNESIUM

Strength

EQ 20MG BASE

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 207920

Product number

001

Marketing status

OTC

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.

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