APPLICATION
ANDA075410
TYPE
ANDA
ORIGINAL APPROVAL
2002-11-01
LATEST ACTION
2023-07-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription
Products
OMEPRAZOLEPrescription
OMEPRAZOLE 20MG · CAPSULE, DELAYED REL PELLETS · ORAL
OMEPRAZOLEPrescription
OMEPRAZOLE 40MG · CAPSULE, DELAYED REL PELLETS · ORAL
OMEPRAZOLEPrescription
OMEPRAZOLE 10MG · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2023-07-18Labeling · Supplement 68 · standardAP
2022-03-04Labeling · Supplement 66 · standardAP
2020-12-01Labeling · Supplement 64 · standardAP
2020-11-27Labeling · Supplement 62 · standardAP
2018-06-07Labeling · Supplement 57 · standardAP
2018-05-31Labeling · Supplement 55 · standardAP
2016-02-25Labeling · Supplement 51 · standardAP
2015-02-27Labeling · Supplement 45 · standardAP
2015-02-27Labeling · Supplement 48 · standardAP
2015-02-27Labeling · Supplement 42 · standardAP
2015-02-27Labeling · Supplement 49 · standardAP
2015-01-30Manufacturing (CMC) · Supplement 43 · unknownAP
2012-11-02Labeling · Supplement 39AP
2012-02-16Labeling · Supplement 37AP
2012-02-16Labeling · Supplement 38AP
2012-02-16Labeling · Supplement 36AP
2012-02-16Labeling · Supplement 34AP
2010-11-17Labeling · Supplement 31AP
2010-11-17Labeling · Supplement 32AP
2009-01-23Labeling · Supplement 16AP
2007-03-21Labeling · Supplement 27AP
2007-03-21Labeling · Supplement 25AP
2006-09-26Labeling · Supplement 24AP
2005-03-24Manufacturing (CMC) · Supplement 15TA
2004-07-14Labeling · Supplement 20AP
2004-04-29Labeling · Supplement 9AP
2004-02-13Labeling · Supplement 13AP
2003-08-06Labeling · Supplement 8AP
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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