APPLICATION
ANDA218829
TYPE
ANDA
ORIGINAL APPROVAL
2025-08-07
LATEST ACTION
2026-06-29
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Over-the-counter
Products
OMEPRAZOLE MAGNESIUMOver-the-counter
OMEPRAZOLE MAGNESIUM EQ 20MG BASE · TABLET, DELAYED RELEASE · ORAL
Approval history
2026-06-29Manufacturing (CMC) · Supplement 2 · unknownAP
2025-08-07UNKNOWN · Original · 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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