APPLICATION
ANDA213725
TYPE
ANDA
ORIGINAL APPROVAL
2020-06-30
LATEST ACTION
2023-11-29
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
PANTOPRAZOLE SODIUMPrescription
PANTOPRAZOLE SODIUM EQ 40MG BASE · FOR SUSPENSION, DELAYED RELEASE · ORAL
Approval history
2023-11-29Labeling · Supplement 6 · standardAP
2022-09-27Labeling · Supplement 4 · standardAP
2021-06-04Labeling · Supplement 1 · 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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