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ESOMEPRAZOLE MAGNESIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2019-05-22

Drug application

FDA Application #

ANDA206296

Application type

Abbreviated New Drug Application (Generic)

Brand name

ESOMEPRAZOLE MAGNESIUM

Generic name

ESOMEPRAZOLE MAGNESIUM

Active ingredients

ESOMEPRAZOLE MAGNESIUM

Dosage form

CAPSULE, DELAYED REL PELLETS

Route

ORAL

Marketing status

Prescription

Sponsor

ZYDUS PHARMS

Manufacturer

Zydus Pharmaceuticals USA Inc.

First approval

2019-05-22

Source

Authoritative

Drugs@FDA application overview

Machine

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