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OMEPRAZOLE AND SODIUM BICARBONATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PERRIGO R AND D · Approved 2016-07-15

Drug application

FDA Application #

ANDA201361

Application type

Abbreviated New Drug Application (Generic)

Brand name

OMEPRAZOLE AND SODIUM BICARBONATE

Generic name

OMEPRAZOLE, SODIUM BICARBONATE

Active ingredients

OMEPRAZOLE; SODIUM BICARBONATE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Over-the-counter

Sponsor

PERRIGO R AND D

Manufacturer

WALMART INC.

First approval

2016-07-15

Source

Authoritative

Drugs@FDA application overview

Machine

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