APPLICATION
ANDA204152
TYPE
ANDA
ORIGINAL APPROVAL
2015-07-30
LATEST ACTION
2026-06-25
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued
Products
OMEPRAZOLE MAGNESIUMDiscontinued
OMEPRAZOLE MAGNESIUM EQ 20MG BASE · TABLET, DELAYED RELEASE · ORAL
Approval history
2026-06-25Labeling · Supplement 10 · standardAP
2026-06-25Labeling · Supplement 8 · standardAP
2026-06-25Labeling · Supplement 6 · standardAP
2018-05-04Manufacturing (CMC) · Supplement 5AP
2016-04-28Labeling · Supplement 1 · standardAP
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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