APPLICATION
ANDA200794
TYPE
ANDA
ORIGINAL APPROVAL
2012-05-02
LATEST ACTION
2015-04-08
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
2015-04-08Labeling · Supplement 5 · standardAP
2015-01-02Labeling · Supplement 4 · standardAP
2015-01-02Labeling · Supplement 3 · standardAP
2013-05-31Labeling · Supplement 2 · standardAP
2013-05-31Labeling · Supplement 1 · standardAP
2012-05-02Not Applicable · OriginalAP
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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