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ESOMEPRAZOLE MAGNESIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA · Approved 2026-09-25

Drug application

FDA Application #

ANDA218687

Application type

Abbreviated New Drug Application (Generic)

Brand name

ESOMEPRAZOLE MAGNESIUM

Generic name

Esomeprazole Magnesium

Active ingredients

ESOMEPRAZOLE MAGNESIUM

Dosage form

FOR SUSPENSION, DELAYED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

NOVITIUM PHARMA

First approval

2026-09-25

Source

Authoritative

Drugs@FDA application overview

Machine

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