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ESOMEPRAZOLE MAGNESIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2016-04-21

Drug application

FDA Application #
ANDA205606
Application type
Abbreviated New Drug Application (Generic)
Brand name
ESOMEPRAZOLE MAGNESIUM
Generic name
ESOMEPRAZOLE MAGNESIUM
Active ingredients
ESOMEPRAZOLE MAGNESIUM
Dosage form
CAPSULE, DELAYED REL PELLETS
Route
ORAL
Marketing status
Prescription
Sponsor
AUROBINDO PHARMA LTD
Manufacturer
Aurobindo Pharma Limited
First approval
2016-04-21

Source

Authoritative
Drugs@FDA application overview
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