APPLICATION
ANDA211368
TYPE
ANDA
ORIGINAL APPROVAL
2019-03-01
LATEST ACTION
2023-09-27
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued
Products
PANTOPRAZOLE SODIUMDiscontinued
PANTOPRAZOLE SODIUM EQ 40MG BASE · TABLET, DELAYED RELEASE · ORAL
Approval history
2023-09-27Labeling · Supplement 6 · standardAP
2022-06-09Labeling · Supplement 4 · standardAP
2022-06-09Labeling · Supplement 3 · standardAP
2019-12-20Labeling · Supplement 2 · standardAP
2019-03-01UNKNOWN · Original · standardAP
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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