APPLICATION
ANDA202376
TYPE
ANDA
ORIGINAL APPROVAL
2013-11-08
LATEST ACTION
2024-04-23
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
RABEPRAZOLE SODIUMPrescription
RABEPRAZOLE SODIUM 20MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2024-04-23Labeling · Supplement 20 · standardAP
2022-09-02Labeling · Supplement 18 · standardAP
2021-09-14Labeling · Supplement 17 · standardAP
2018-11-30Labeling · Supplement 14 · standardAP
2018-11-30Labeling · Supplement 8 · standardAP
2018-11-30Labeling · Supplement 10 · standardAP
2018-11-30Labeling · Supplement 13 · standardAP
2015-04-02Labeling · Supplement 4 · standardAP
2015-04-02Labeling · Supplement 5 · standardAP
2013-11-08UNKNOWN · 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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