APPLICATION
ANDA200821
TYPE
ANDA
ORIGINAL APPROVAL
2012-02-16
LATEST ACTION
2024-08-30
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued
Products
PANTOPRAZOLE SODIUMDiscontinued
PANTOPRAZOLE SODIUM EQ 40MG BASE · TABLET, DELAYED RELEASE · ORAL
PANTOPRAZOLE SODIUMDiscontinued
PANTOPRAZOLE SODIUM EQ 20MG BASE · TABLET, DELAYED RELEASE · ORAL
Approval history
2024-08-30Labeling · Supplement 26 · standardAP
2024-08-30Labeling · Supplement 27 · standardAP
2024-08-30Labeling · Supplement 33 · standardAP
2024-08-30Labeling · Supplement 23 · standardAP
2019-09-13Labeling · Supplement 12 · standardAP
2019-09-13Labeling · Supplement 10 · standardAP
2019-09-13Labeling · Supplement 8 · standardAP
2019-09-13Labeling · Supplement 19 · standardAP
2019-09-13Labeling · Supplement 15 · standardAP
2016-09-23Manufacturing (CMC) · Supplement 7 · unknownAP
2015-04-09Labeling · Supplement 4 · standardAP
2013-06-12Labeling · Supplement 3 · standardAP
2013-06-12Labeling · Supplement 1 · standardAP
2012-02-16UNKNOWN · 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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