APPLICATION
ANDA090296
TYPE
ANDA
ORIGINAL APPROVAL
2015-07-14
LATEST ACTION
2025-10-01
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PANTOPRAZOLE SODIUMDiscontinued
PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL · INJECTABLE · INTRAVENOUS
Approval history
2025-10-01Labeling · Supplement 13 · standardAP
2025-10-01Labeling · Supplement 11 · standardAP
2025-10-01Labeling · Supplement 12 · standardAP
2022-07-28Labeling · Supplement 8 · standardAP
2021-03-05Labeling · Supplement 7 · standardAP
2019-09-16Labeling · Supplement 6 · standardAP
2019-09-16Labeling · Supplement 2 · standardAP
2019-09-16Labeling · Supplement 5 · standardAP
2019-09-16Labeling · Supplement 3 · standardAP
2015-07-14OriginalAP
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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