APPLICATION
ANDA075757
TYPE
ANDA
ORIGINAL APPROVAL
2003-01-28
LATEST ACTION
2023-10-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription
Products
OMEPRAZOLEPrescription
OMEPRAZOLE 10MG · CAPSULE, DELAYED REL PELLETS · ORAL
OMEPRAZOLEPrescription
OMEPRAZOLE 20MG · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2023-10-11Labeling · Supplement 56 · standardAP
2022-03-04Labeling · Supplement 54 · standardAP
2020-11-27Labeling · Supplement 52 · standardAP
2018-06-07Labeling · Supplement 49 · standardAP
2017-09-28Labeling · Supplement 46 · standardAP
2015-04-14Labeling · Supplement 39 · standardAP
2015-04-14Labeling · Supplement 43 · standardAP
2015-04-14Labeling · Supplement 38 · standardAP
2015-04-14Labeling · Supplement 42 · standardAP
2014-10-31Manufacturing (CMC) · Supplement 32AP
2013-12-31Labeling · Supplement 33 · standardAP
2013-12-31Labeling · Supplement 36 · standardAP
2012-09-19Labeling · Supplement 31 · standardAP
2012-02-13Labeling · Supplement 29AP
2012-02-13Labeling · Supplement 27AP
2012-02-13Labeling · Supplement 28AP
2011-01-07Labeling · Supplement 25AP
2010-02-26Labeling · Supplement 20AP
2007-11-16Labeling · Supplement 16AP
2007-03-21Labeling · Supplement 11AP
2006-08-24Labeling · Supplement 13AP
2005-09-29Labeling · Supplement 7AP
2005-07-12Labeling · Supplement 8AP
2004-05-19Labeling · Supplement 4AP
2003-01-28OriginalAP
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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