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ESOMEPRAZOLE MAGNESIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2025-04-15

Drug application

FDA Application #
ANDA219213
Application type
Abbreviated New Drug Application (Generic)
Brand name
ESOMEPRAZOLE MAGNESIUM
Generic name
ESOMEPRAZOLE MAGNESIUM
Active ingredients
ESOMEPRAZOLE MAGNESIUM
Dosage form
FOR SUSPENSION, DELAYED RELEASE
Route
ORAL
Marketing status
Prescription
Sponsor
AUROBINDO PHARMA LTD
Manufacturer
Aurobindo Pharma Limited
First approval
2025-04-15

Source

Authoritative
Drugs@FDA application overview
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