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OMEPRAZOLE AND SODIUM BICARBONATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2018-05-25

Drug application

FDA Application #
ANDA203290
Application type
Abbreviated New Drug Application (Generic)
Brand name
OMEPRAZOLE AND SODIUM BICARBONATE
Generic name
Omeprazole
Active ingredients
OMEPRAZOLE; SODIUM BICARBONATE
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription
Sponsor
ZYDUS PHARMS
First approval
2018-05-25

Source

Authoritative
Drugs@FDA application overview
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