APPLICATION
ANDA216247
TYPE
ANDA
ORIGINAL APPROVAL
2023-06-16
LATEST ACTION
2024-04-05
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
2024-04-05Labeling · Supplement 2 · standardAP
2024-04-05Labeling · Supplement 1 · standardAP
2023-06-16UNKNOWN · 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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