APPLICATION
ANDA215732
TYPE
ANDA
ORIGINAL APPROVAL
2022-02-10
LATEST ACTION
2024-02-08
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ESOMEPRAZOLE SODIUMPrescription
ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL · INJECTABLE · INTRAVENOUS
Approval history
2024-02-08Labeling · Supplement 2 · standardAP
2023-02-01Labeling · Supplement 1 · standardAP
2022-02-10UNKNOWN · 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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