APPLICATION
ANDA207740
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-05
LATEST ACTION
2026-04-29
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Over-the-counter
Products
OMEPRAZOLEOver-the-counter
OMEPRAZOLE 20MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2026-04-29Manufacturing (CMC) · Supplement 9 · unknownAP
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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