APPLICATION
ANDA202052
TYPE
ANDA
ORIGINAL APPROVAL
2014-12-02
LATEST ACTION
2024-04-16
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
PANTOPRAZOLE SODIUMPrescription
PANTOPRAZOLE SODIUM EQ 20MG BASE · TABLET, DELAYED RELEASE · ORAL
PANTOPRAZOLE SODIUMPrescription
PANTOPRAZOLE SODIUM EQ 40MG BASE · TABLET, DELAYED RELEASE · ORAL
Approval history
2024-04-16Labeling · Supplement 10 · standardAP
2022-08-15Labeling · Supplement 8 · standardAP
2022-08-15Labeling · Supplement 9 · standardAP
2019-07-22Labeling · Supplement 6 · standardAP
2019-07-22Labeling · Supplement 2 · standardAP
2019-07-22Labeling · Supplement 7 · standardAP
2019-07-22Labeling · Supplement 5 · standardAP
2019-07-22Labeling · Supplement 3 · standardAP
2015-04-08Labeling · Supplement 1 · standardAP
2014-12-02Not Applicable · OriginalAP
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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