APPLICATION
ANDA213859
TYPE
ANDA
ORIGINAL APPROVAL
2020-11-18
LATEST ACTION
2024-07-17
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
2024-07-17Labeling · Supplement 7 · standardAP
2024-07-17Labeling · Supplement 10 · standardAP
2022-01-13Labeling · Supplement 1 · standardAP
2020-11-18UNKNOWN · 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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