APPLICATION
ANDA216349
TYPE
ANDA
ORIGINAL APPROVAL
2022-06-24
LATEST ACTION
2023-05-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Over-the-counter
Products
ESOMEPRAZOLE MAGNESIUMOver-the-counter
ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE · CAPSULE, DELAYED RELEASE · ORAL
Approval history
2023-05-15Labeling · Supplement 2 · standardAP
2022-06-24UNKNOWN · 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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