APPLICATION
ANDA090901
TYPE
ANDA
ORIGINAL APPROVAL
2011-08-30
LATEST ACTION
2020-02-04
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
2020-02-04Labeling · Supplement 17 · standardAP
2020-02-04Labeling · Supplement 15 · standardAP
2020-02-04Labeling · Supplement 22 · standardAP
2015-12-07Labeling · Supplement 12 · standardAP
2014-12-21Labeling · Supplement 8 · standardAP
2014-12-21Labeling · Supplement 9 · standardAP
2013-05-30Labeling · Supplement 5 · standardAP
2012-10-16Labeling · Supplement 4 · standardAP
2012-10-16Labeling · Supplement 2AP
2012-10-16Labeling · Supplement 3 · standardAP
2011-08-30OriginalAP
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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