APPLICATION
ANDA209735
TYPE
ANDA
ORIGINAL APPROVAL
2018-04-30
LATEST ACTION
2023-11-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription
Products
ESOMEPRAZOLE MAGNESIUMPrescription
ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
ESOMEPRAZOLE MAGNESIUMPrescription
ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2023-11-15Labeling · Supplement 16 · standardAP
2023-05-22Labeling · Supplement 13 · standardAP
2023-05-22Labeling · Supplement 11 · standardAP
2023-05-22Labeling · Supplement 9 · standardAP
2018-07-23Labeling · Supplement 3 · standardAP
2018-04-30UNKNOWN · Original · 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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