APPLICATION
ANDA090807
TYPE
ANDA
ORIGINAL APPROVAL
2012-05-02
LATEST ACTION
2019-11-13
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
PANTOPRAZOLE SODIUMPrescription
PANTOPRAZOLE SODIUM EQ 20MG BASE · TABLET, DELAYED RELEASE · ORAL
PANTOPRAZOLE SODIUMPrescription
PANTOPRAZOLE SODIUM EQ 40MG BASE · TABLET, DELAYED RELEASE · ORAL
Approval history
2019-11-13Labeling · Supplement 5 · standardAP
2019-11-13Labeling · Supplement 8 · standardAP
2019-11-13Labeling · Supplement 6 · standardAP
2019-11-13Labeling · Supplement 9 · standardAP
2019-11-13Labeling · Supplement 7 · standardAP
2015-04-08Labeling · Supplement 4 · standardAP
2014-12-13Labeling · Supplement 3 · standardAP
2014-12-13Labeling · Supplement 2 · standardAP
2013-05-30Labeling · Supplement 1 · standardAP
2012-05-02OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.