APPLICATION
ANDA090797
TYPE
ANDA
ORIGINAL APPROVAL
2011-02-07
LATEST ACTION
2024-03-13
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued
Products
PANTOPRAZOLE SODIUMDiscontinued
PANTOPRAZOLE SODIUM EQ 20MG BASE · TABLET, DELAYED RELEASE · ORAL
PANTOPRAZOLE SODIUMDiscontinued
PANTOPRAZOLE SODIUM EQ 40MG BASE · TABLET, DELAYED RELEASE · ORAL
Approval history
2024-03-13Labeling · Supplement 14 · standardAP
2024-03-13Labeling · Supplement 12 · standardAP
2024-03-13Labeling · Supplement 15 · standardAP
2024-03-13Labeling · Supplement 13 · standardAP
2015-04-09Labeling · Supplement 11 · standardAP
2014-12-10Labeling · Supplement 10 · standardAP
2014-12-10Labeling · Supplement 9 · standardAP
2013-05-30Labeling · Supplement 7 · standardAP
2013-05-30Labeling · Supplement 6 · standardAP
2012-03-23Labeling · Supplement 4AP
2011-02-07OriginalAP
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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