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OMEPRAZOLE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: XIROMED · Approved 2020-12-10

Drug application

FDA Application #

ANDA212977

Application type

Abbreviated New Drug Application (Generic)

Brand name

OMEPRAZOLE

Generic name

OMEPRAZOLE

Active ingredients

OMEPRAZOLE

Dosage form

CAPSULE, DELAYED REL PELLETS

Route

ORAL

Marketing status

Prescription

Sponsor

XIROMED

Manufacturer

Golden State Medical Supply, Inc.

First approval

2020-12-10

Source

Authoritative

Drugs@FDA application overview

Machine

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