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ESOMEPRAZOLE MAGNESIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GRAVITI PHARMS · Approved 2022-06-24

Drug application

FDA Application #
ANDA216349
Application type
Abbreviated New Drug Application (Generic)
Brand name
ESOMEPRAZOLE MAGNESIUM
Generic name
ESOMEPRAZOLE MAGNESIUM
Active ingredients
ESOMEPRAZOLE MAGNESIUM
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Marketing status
Over-the-counter
Sponsor
GRAVITI PHARMS
Manufacturer
Rising Pharma Holdings, Inc.
First approval
2022-06-24

Source

Authoritative
Drugs@FDA application overview
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