APPLICATION
ANDA209495
TYPE
ANDA
ORIGINAL APPROVAL
2019-05-10
LATEST ACTION
2023-11-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Discontinued
Products
ESOMEPRAZOLE MAGNESIUMDiscontinued
ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
ESOMEPRAZOLE MAGNESIUMDiscontinued
ESOMEPRAZOLE MAGNESIUM EQ 40MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2023-11-20Labeling · Supplement 1 · standardAP
2023-11-20Labeling · Supplement 4 · standardAP
2023-11-20Labeling · Supplement 2 · standardAP
2023-11-20Labeling · Supplement 7 · standardAP
2019-05-10UNKNOWN · 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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