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ESOMEPRAZOLE MAGNESIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2023-07-12

Drug application

FDA Application #
ANDA214473
Application type
Abbreviated New Drug Application (Generic)
Brand name
ESOMEPRAZOLE MAGNESIUM
Generic name
ESOMEPRAZOLE MAGNESIUM
Active ingredients
ESOMEPRAZOLE MAGNESIUM
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Marketing status
Over-the-counter
Sponsor
AUROBINDO PHARMA LTD
Manufacturer
Aurohealth LLC
First approval
2023-07-12

Source

Authoritative
Drugs@FDA application overview
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