APPLICATION
ANDA205761
TYPE
ANDA
ORIGINAL APPROVAL
2017-02-17
LATEST ACTION
2023-10-31
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
RABEPRAZOLE SODIUMPrescription
RABEPRAZOLE SODIUM 20MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2023-10-31Labeling · Supplement 11 · standardAP
2022-09-14Labeling · Supplement 7 · standardAP
2021-08-30Labeling · Supplement 6 · standardAP
2019-02-01Labeling · Supplement 2 · standardAP
2019-02-01Labeling · Supplement 3 · standardAP
2017-02-17UNKNOWN · 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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