APPLICATION
ANDA076885
TYPE
ANDA
ORIGINAL APPROVAL
2013-11-08
LATEST ACTION
2023-10-31
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued
Products
RABEPRAZOLE SODIUMDiscontinued
RABEPRAZOLE SODIUM 20MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2023-10-31Labeling · Supplement 11 · standardAP
2023-10-31Labeling · Supplement 10 · standardAP
2019-02-07Labeling · Supplement 5 · standardAP
2019-02-07Labeling · Supplement 8 · standardAP
2019-02-07Labeling · Supplement 6 · standardAP
2019-02-07Labeling · Supplement 4 · standardAP
2015-04-03Labeling · Supplement 3 · standardAP
2015-04-03Labeling · Supplement 2 · 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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