APPLICATION
ANDA204237
TYPE
ANDA
ORIGINAL APPROVAL
2015-11-18
LATEST ACTION
2026-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
RABEPRAZOLE SODIUMPrescription
RABEPRAZOLE SODIUM 20MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2026-06-05Labeling · Supplement 18 · standardAP
2023-03-30Labeling · Supplement 14 · standardAP
2023-03-30Labeling · Supplement 13 · standardAP
2019-11-29Labeling · Supplement 8 · standardAP
2019-11-29Labeling · Supplement 6 · standardAP
2019-11-29Labeling · Supplement 2 · standardAP
2015-11-18UNKNOWN · 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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