APPLICATION
ANDA205119
TYPE
ANDA
ORIGINAL APPROVAL
2016-01-26
LATEST ACTION
2024-11-27
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
2024-11-27Labeling · Supplement 15 · standardAP
2024-11-27Labeling · Supplement 13 · standardAP
2024-11-27Labeling · Supplement 16 · standardAP
2024-11-27Labeling · Supplement 19 · standardAP
2019-09-16Labeling · Supplement 7 · standardAP
2019-09-16Labeling · Supplement 5 · standardAP
2019-09-16Labeling · Supplement 3 · standardAP
2019-09-16Labeling · Supplement 4 · standardAP
2019-09-16Labeling · Supplement 2 · standardAP
2016-01-26UNKNOWN · 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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