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FDA NDA · NDA214278

ESOMEPRAZOLE MAGNESIUM

Sponsor: DEXCEL

APPLICATION
NDA214278
TYPE
NDA
ORIGINAL APPROVAL
2020-10-20
LATEST ACTION
2022-05-11
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

ESOMEPRAZOLE MAGNESIUM · ReferenceDiscontinued
ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE · TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE · ORAL

Approval history

2022-05-11Labeling · Supplement 2 · standard — Letter ↗AP
2021-09-07Labeling · Supplement 1 · standard — Letter ↗AP
2020-10-20Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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