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FDA ANDA · ANDA212651

ESOMEPRAZOLE MAGNESIUM FOR DELAYED-RELEASE ORAL SUSPENSION

esomeprazole magnesium

Sponsor: TORRENT

APPLICATION
ANDA212651
TYPE
ANDA
ORIGINAL APPROVAL
2025-03-05
LATEST ACTION
2025-03-05
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

ESOMEPRAZOLE MAGNESIUMPrescription
ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE/PACKET · FOR SUSPENSION, DELAYED RELEASE · ORAL
ESOMEPRAZOLE MAGNESIUMPrescription
ESOMEPRAZOLE MAGNESIUM EQ 5MG BASE/PACKET · FOR SUSPENSION, DELAYED RELEASE · ORAL
ESOMEPRAZOLE MAGNESIUMPrescription
ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE/PACKET · FOR SUSPENSION, DELAYED RELEASE · ORAL
ESOMEPRAZOLE MAGNESIUMPrescription
ESOMEPRAZOLE MAGNESIUM EQ 2.5MG BASE/PACKET · FOR SUSPENSION, DELAYED RELEASE · ORAL

Approval history

2025-03-05UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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