APPLICATION
ANDA213778
TYPE
ANDA
ORIGINAL APPROVAL
2022-05-18
LATEST ACTION
2025-10-15
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PANTOPRAZOLE SODIUMPrescription
PANTOPRAZOLE SODIUM EQ 40MG BASE/VIAL · INJECTABLE · INTRAVENOUS
Approval history
2025-10-15Labeling · Supplement 12 · standardAP
2025-10-15Labeling · Supplement 13 · standardAP
2023-10-05Labeling · Supplement 7 · standardAP
2022-05-18UNKNOWN · 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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