APPLICATION
ANDA205675
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-30
LATEST ACTION
2025-04-25
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PANTOPRAZOLE SODIUMPrescription
PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL · INJECTABLE · INTRAVENOUS
Approval history
2025-04-25Labeling · Supplement 25 · standardAP
2025-04-25Labeling · Supplement 26 · standardAP
2024-03-05Labeling · Supplement 23 · standardAP
2023-08-02Labeling · Supplement 20 · standardAP
2022-07-28Labeling · Supplement 17 · standardAP
2021-03-19Labeling · Supplement 13 · standardAP
2020-04-20Manufacturing (CMC) · Supplement 12 · unknownAP
2019-09-17Labeling · Supplement 5 · standardAP
2019-09-17Labeling · Supplement 1 · standardAP
2019-09-17Labeling · Supplement 11 · standardAP
2019-09-17Labeling · Supplement 8 · standardAP
2019-09-17Labeling · Supplement 6 · standardAP
2016-03-30UNKNOWN · 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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