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ESOMEPRAZOLE MAGNESIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GUANGZHOU NOVAKEN · Approved 2020-11-18

Drug application

FDA Application #

ANDA213859

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

GUANGZHOU NOVAKEN

Manufacturer

Somerset Therapeutics, LLC

First approval

2020-11-18

Source

Authoritative

Drugs@FDA application overview

Machine

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