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ESOMEPRAZOLE MAGNESIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA · Approved 2017-10-16

Drug application

FDA Application #

ANDA209339

Application type

Abbreviated New Drug Application (Generic)

Brand name

ESOMEPRAZOLE MAGNESIUM

Generic name

ESOMEPRAZOLE MAGNESIUM

Active ingredients

ESOMEPRAZOLE MAGNESIUM

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

Marketing status

Over-the-counter

Sponsor

AUROBINDO PHARMA

Manufacturer

Wal-Mart Stores, Inc.

First approval

2017-10-16

Source

Authoritative

Drugs@FDA application overview

Machine

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