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OMEPRAZOLE MAGNESIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: DEXCEL · Approved 2022-05-24

Drug application

FDA Application #
ANDA216096
Application type
Abbreviated New Drug Application (Generic)
Brand name
OMEPRAZOLE MAGNESIUM
Generic name
OMEPRAZOLE MAGNESIUM
Active ingredients
OMEPRAZOLE MAGNESIUM
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Marketing status
Over-the-counter
Sponsor
DEXCEL
Manufacturer
Meijer, Inc.
First approval
2022-05-24

Source

Authoritative
Drugs@FDA application overview
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