APPLICATION
ANDA204657
TYPE
ANDA
ORIGINAL APPROVAL
2016-08-10
LATEST ACTION
2024-02-23
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ESOMEPRAZOLE SODIUMDiscontinued
ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL · INJECTABLE · INTRAVENOUS
ESOMEPRAZOLE SODIUMDiscontinued
ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL · INJECTABLE · INTRAVENOUS
Approval history
2024-02-23Labeling · Supplement 7 · standardAP
2024-02-23Labeling · Supplement 5 · standardAP
2024-02-23Labeling · Supplement 3 · standardAP
2024-02-23Labeling · Supplement 8 · standardAP
2024-02-23Labeling · Supplement 6 · standardAP
2024-02-23Labeling · Supplement 4 · standardAP
2024-02-23Labeling · Supplement 2 · standardAP
2016-08-10UNKNOWN · OriginalAP
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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