APPLICATION
ANDA077674
TYPE
ANDA
ORIGINAL APPROVAL
2019-08-19
LATEST ACTION
2025-04-17
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PANTOPRAZOLE SODIUMDiscontinued
PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL · INJECTABLE · INTRAVENOUS
Approval history
2025-04-17Labeling · Supplement 15 · standardAP
2025-04-17Labeling · Supplement 12 · standardAP
2023-10-05Labeling · Supplement 10 · standardAP
2022-12-13Labeling · Supplement 8 · standardAP
2021-03-05Labeling · Supplement 5 · standardAP
2019-08-19OriginalAP
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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