APPLICATION
ANDA090970
TYPE
ANDA
ORIGINAL APPROVAL
2011-01-19
LATEST ACTION
2023-11-16
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
PANTOPRAZOLE SODIUMPrescription
PANTOPRAZOLE SODIUM EQ 40MG BASE · TABLET, DELAYED RELEASE · ORAL
PANTOPRAZOLE SODIUMPrescription
PANTOPRAZOLE SODIUM EQ 20MG BASE · TABLET, DELAYED RELEASE · ORAL
Approval history
2023-11-16Labeling · Supplement 31 · standardAP
2023-04-06Labeling · Supplement 24 · standardAP
2023-04-06Labeling · Supplement 22 · standardAP
2019-09-16Labeling · Supplement 17 · standardAP
2019-09-16Labeling · Supplement 15 · standardAP
2019-09-16Labeling · Supplement 18 · standardAP
2019-09-16Labeling · Supplement 14 · standardAP
2019-09-16Labeling · Supplement 12 · standardAP
2015-04-08Labeling · Supplement 8 · standardAP
2015-04-08Labeling · Supplement 9 · standardAP
2013-08-07Labeling · Supplement 6 · standardAP
2012-09-07Labeling · Supplement 3AP
2012-01-11Labeling · Supplement 2AP
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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