APPLICATION
ANDA202038
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-28
LATEST ACTION
2023-09-26
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
2023-09-26Labeling · Supplement 25 · standardAP
2022-06-09Labeling · Supplement 22 · standardAP
2022-06-09Labeling · Supplement 23 · standardAP
2019-11-14Labeling · Supplement 18 · standardAP
2019-11-14Labeling · Supplement 12 · standardAP
2019-11-14Labeling · Supplement 10 · standardAP
2019-11-14Labeling · Supplement 15 · standardAP
2019-11-14Labeling · Supplement 13 · standardAP
2016-04-04Manufacturing (CMC) · Supplement 9 · unknownAP
2015-04-08Labeling · Supplement 6 · standardAP
2015-01-02Labeling · Supplement 4 · standardAP
2013-06-13Labeling · Supplement 3 · standardAP
2013-06-13Labeling · Supplement 2 · standardAP
2012-09-28Not 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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