APPLICATION
ANDA090074
TYPE
ANDA
ORIGINAL APPROVAL
2011-01-19
LATEST ACTION
2023-09-27
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
2023-09-27Labeling · Supplement 28 · standardAP
2022-08-11Labeling · Supplement 26 · standardAP
2022-01-07Labeling · Supplement 24 · standardAP
2019-11-14Labeling · Supplement 18 · standardAP
2019-11-14Labeling · Supplement 16 · standardAP
2019-11-14Labeling · Supplement 22 · standardAP
2019-11-14Labeling · Supplement 19 · standardAP
2015-04-09Labeling · Supplement 12 · standardAP
2015-02-25Labeling · Supplement 10 · standardAP
2014-12-05Labeling · Supplement 11 · standardAP
2013-05-30Labeling · Supplement 8 · standardAP
2013-05-30Labeling · Supplement 6 · standardAP
2012-01-17Labeling · Supplement 4AP
2011-01-19OriginalAP
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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