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ESOMEPRAZOLE MAGNESIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GRAVITI PHARMS · Approved 2021-03-19

Drug application

FDA Application #

ANDA213486

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

GRAVITI PHARMS

Manufacturer

Biocon Pharma Inc.,

First approval

2021-03-19

Source

Authoritative

Drugs@FDA application overview

Machine

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