APPLICATION
ANDA075576
TYPE
ANDA
ORIGINAL APPROVAL
2007-10-22
LATEST ACTION
2023-07-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription
Products
OMEPRAZOLEPrescription
OMEPRAZOLE 10MG · CAPSULE, DELAYED REL PELLETS · ORAL
OMEPRAZOLEPrescription
OMEPRAZOLE 40MG · CAPSULE, DELAYED REL PELLETS · ORAL
OMEPRAZOLEPrescription
OMEPRAZOLE 20MG · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2023-07-18Labeling · Supplement 25 · standardAP
2022-03-04Labeling · Supplement 22 · standardAP
2020-11-27Labeling · Supplement 20 · standardAP
2018-06-07Labeling · Supplement 19 · standardAP
2018-05-31Labeling · Supplement 16 · standardAP
2018-05-31Labeling · Supplement 17 · standardAP
2015-03-20Labeling · Supplement 15 · standardAP
2015-01-02Labeling · Supplement 11 · standardAP
2015-01-02Labeling · Supplement 14 · standardAP
2015-01-02Labeling · Supplement 12 · standardAP
2012-08-23Labeling · Supplement 9AP
2012-02-09Labeling · Supplement 6AP
2012-02-09Labeling · Supplement 7AP
2012-02-09Labeling · Supplement 5AP
2010-11-23Labeling · Supplement 4AP
2010-11-23Labeling · Supplement 3AP
2009-01-21Labeling · Supplement 1AP
2007-10-22OriginalAP
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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