APPLICATION
ANDA075347
TYPE
ANDA
ORIGINAL APPROVAL
2008-05-30
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 30 · standardAP
2022-03-04Labeling · Supplement 29 · standardAP
2020-11-27Labeling · Supplement 27 · standardAP
2018-06-07Labeling · Supplement 24 · standardAP
2018-05-31Labeling · Supplement 22 · standardAP
2018-05-31Labeling · Supplement 23 · standardAP
2015-04-01Labeling · Supplement 18 · standardAP
2015-04-01Labeling · Supplement 20 · standardAP
2012-09-17Labeling · Supplement 14 · standardAP
2012-03-09Labeling · Supplement 13AP
2012-03-09Labeling · Supplement 7AP
2012-03-09Labeling · Supplement 12AP
2002-12-24Manufacturing (CMC) · Supplement 2AP
2002-10-04Manufacturing (CMC) · Supplement 4AP
2002-10-04Labeling · Supplement 5AP
2002-07-31Manufacturing (CMC) · Supplement 1AP
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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