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OMEPRAZOLE AND SODIUM BICARBONATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AJANTA PHARMA LTD · Approved 2016-07-27

Drug application

FDA Application #

ANDA205545

Application type

Abbreviated New Drug Application (Generic)

Brand name

OMEPRAZOLE AND SODIUM BICARBONATE

Generic name

OMEPRAZOLE AND SODIUM BICARBONATE

Active ingredients

OMEPRAZOLE; SODIUM BICARBONATE

Dosage form

FOR SUSPENSION

Route

ORAL

Marketing status

Prescription

Sponsor

AJANTA PHARMA LTD

Manufacturer

Ajanta Pharma USA Inc.

First approval

2016-07-27

Source

Authoritative

Drugs@FDA application overview

Machine

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