APPLICATION
ANDA211751
TYPE
ANDA
ORIGINAL APPROVAL
2020-03-23
LATEST ACTION
2023-09-11
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
ESOMEPRAZOLE MAGNESIUMPrescription
ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE/PACKET · FOR SUSPENSION, DELAYED RELEASE · ORAL
ESOMEPRAZOLE MAGNESIUMPrescription
ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE/PACKET · FOR SUSPENSION, DELAYED RELEASE · ORAL
Approval history
2023-09-11Labeling · Supplement 6 · standardAP
2023-09-11Labeling · Supplement 4 · standardAP
2023-09-11Labeling · Supplement 2 · standardAP
2023-09-11Labeling · Supplement 3 · standardAP
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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