APPLICATION
ANDA075876
TYPE
ANDA
ORIGINAL APPROVAL
2003-05-29
LATEST ACTION
2023-07-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Discontinued
Products
OMEPRAZOLEDiscontinued
OMEPRAZOLE 20MG · CAPSULE, DELAYED REL PELLETS · ORAL
OMEPRAZOLEDiscontinued
OMEPRAZOLE 40MG · CAPSULE, DELAYED REL PELLETS · ORAL
OMEPRAZOLEDiscontinued
OMEPRAZOLE 10MG · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2023-07-18Labeling · Supplement 45 · standardAP
2022-03-04Labeling · Supplement 44 · standardAP
2020-11-27Labeling · Supplement 42 · standardAP
2018-06-07Labeling · Supplement 41 · standardAP
2018-05-31Labeling · Supplement 40 · standardAP
2018-05-31Labeling · Supplement 39 · standardAP
2015-03-20Labeling · Supplement 36 · standardAP
2015-03-20Labeling · Supplement 37 · standardAP
2015-03-20Labeling · Supplement 33 · standardAP
2014-09-03Manufacturing (CMC) · Supplement 32AP
2012-08-09Labeling · Supplement 26AP
2012-08-09Labeling · Supplement 30AP
2012-08-09Labeling · Supplement 27AP
2012-06-14Manufacturing (CMC) · Supplement 28AP
2010-11-23Labeling · Supplement 25AP
2009-01-21Labeling · Supplement 8AP
2008-07-31Labeling · Supplement 18AP
2007-03-21Labeling · Supplement 15AP
2006-09-26Labeling · Supplement 14AP
2005-11-21Labeling · Supplement 9AP
2004-06-01Labeling · Supplement 7AP
2004-03-19Labeling · Supplement 6AP
2003-05-29OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.