APPLICATION
ANDA204179
TYPE
ANDA
ORIGINAL APPROVAL
2015-07-31
LATEST ACTION
2024-11-05
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
RABEPRAZOLE SODIUMPrescription
RABEPRAZOLE SODIUM 20MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2024-11-05Labeling · Supplement 8 · standardAP
2024-11-05Labeling · Supplement 12 · standardAP
2024-11-05Labeling · Supplement 10 · standardAP
2024-11-05Labeling · Supplement 9 · standardAP
2019-11-15Labeling · Supplement 4 · standardAP
2019-11-15Labeling · Supplement 2 · standardAP
2019-11-15Labeling · Supplement 5 · standardAP
2019-11-15Labeling · Supplement 3 · standardAP
2015-07-31UNKNOWN · 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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