APPLICATION
ANDA077058
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-10
LATEST ACTION
2015-04-08
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
2015-04-08Labeling · Supplement 16 · standardAP
2014-12-10Labeling · Supplement 14 · standardAP
2014-12-10Labeling · Supplement 12 · standardAP
2013-04-30Labeling · Supplement 10 · standardAP
2012-01-17Labeling · Supplement 9AP
2011-07-29Labeling · Supplement 6AP
2011-07-29Labeling · Supplement 7AP
2009-08-31Labeling · Supplement 4AP
2007-09-10OriginalAP
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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