APPLICATION
ANDA091352
TYPE
ANDA
ORIGINAL APPROVAL
2012-11-19
LATEST ACTION
2023-07-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription
Products
OMEPRAZOLEPrescription
OMEPRAZOLE 40MG · CAPSULE, DELAYED REL PELLETS · ORAL
OMEPRAZOLEPrescription
OMEPRAZOLE 10MG · CAPSULE, DELAYED REL PELLETS · ORAL
OMEPRAZOLEPrescription
OMEPRAZOLE 20MG · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2023-07-18Labeling · Supplement 23 · standardAP
2022-03-04Labeling · Supplement 21 · standardAP
2020-11-27Labeling · Supplement 18 · standardAP
2020-11-27Labeling · Supplement 20 · standardAP
2018-06-07Labeling · Supplement 12 · standardAP
2018-05-31Labeling · Supplement 10 · standardAP
2018-05-31Labeling · Supplement 9 · standardAP
2015-03-02Labeling · Supplement 8 · standardAP
2014-12-13Labeling · Supplement 5 · standardAP
2014-12-13Labeling · Supplement 3 · standardAP
2014-12-13Labeling · Supplement 7 · standardAP
2012-11-19Not Applicable · 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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