APPLICATION
ANDA090678
TYPE
ANDA
ORIGINAL APPROVAL
2013-11-08
LATEST ACTION
2023-11-01
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
RABEPRAZOLE SODIUMPrescription
RABEPRAZOLE SODIUM 20MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2023-11-01Labeling · Supplement 18 · standardAP
2023-11-01Labeling · Supplement 16 · standardAP
2023-11-01Labeling · Supplement 14 · standardAP
2023-11-01Labeling · Supplement 13 · standardAP
2019-02-07Labeling · Supplement 10 · standardAP
2019-02-07Labeling · Supplement 7 · standardAP
2019-02-07Labeling · Supplement 5 · standardAP
2019-02-07Labeling · Supplement 6 · standardAP
2015-04-03Labeling · Supplement 4 · standardAP
2015-04-03Labeling · Supplement 3 · 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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