APPLICATION
ANDA206877
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-06
LATEST ACTION
2024-11-08
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
2024-11-08Labeling · Supplement 8 · standardAP
2024-11-08Labeling · Supplement 12 · standardAP
2024-11-08Labeling · Supplement 5 · standardAP
2024-11-08Labeling · Supplement 3 · 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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