APPLICATION
ANDA077056
TYPE
ANDA
ORIGINAL APPROVAL
2007-08-02
LATEST ACTION
2022-08-11
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
2022-08-11Labeling · Supplement 26 · standardAP
2022-08-11Labeling · Supplement 18 · standardAP
2022-08-11Labeling · Supplement 20 · standardAP
2022-08-11Labeling · Supplement 19 · standardAP
2022-08-11Labeling · Supplement 25 · standardAP
2022-08-11Labeling · Supplement 23 · standardAP
2022-08-11Labeling · Supplement 21 · standardAP
2015-04-08Labeling · Supplement 16 · standardAP
2014-12-05Labeling · Supplement 12 · standardAP
2014-12-05Labeling · Supplement 15 · standardAP
2013-05-03Labeling · Supplement 10 · standardAP
2012-10-03Labeling · Supplement 8AP
2012-10-03Labeling · Supplement 9 · standardAP
2011-07-31Labeling · Supplement 7AP
2011-03-31Labeling · Supplement 6AP
2011-03-31Labeling · Supplement 5AP
2009-05-21Labeling · Supplement 3AP
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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