APPLICATION
ANDA203349
TYPE
ANDA
ORIGINAL APPROVAL
2020-04-01
LATEST ACTION
2023-03-08
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ESOMEPRAZOLE SODIUMPrescription
ESOMEPRAZOLE SODIUM EQ 20MG BASE/VIAL · INJECTABLE · INTRAVENOUS
ESOMEPRAZOLE SODIUMPrescription
ESOMEPRAZOLE SODIUM EQ 40MG BASE/VIAL · INJECTABLE · INTRAVENOUS
Approval history
2023-03-08Labeling · Supplement 2 · standardAP
2023-03-08Labeling · Supplement 3 · standardAP
2020-04-01UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.