APPLICATION
ANDA208333
TYPE
ANDA
ORIGINAL APPROVAL
2017-10-20
LATEST ACTION
2024-12-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription
Products
ESOMEPRAZOLE MAGNESIUMPrescription
ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
ESOMEPRAZOLE MAGNESIUMPrescription
ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2024-12-10Labeling · Supplement 8 · standardAP
2024-12-10Labeling · Supplement 6 · standardAP
2024-12-10Labeling · Supplement 9 · standardAP
2024-12-10Labeling · Supplement 7 · standardAP
2024-12-10Labeling · Supplement 5 · standardAP
2020-04-20Labeling · Supplement 2 · standardAP
2017-10-20UNKNOWN · 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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