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FDA NDA · NDA202342

ESOMEPRAZOLE STRONTIUM

Sponsor: BELCHER

APPLICATION
NDA202342
TYPE
NDA
ORIGINAL APPROVAL
2013-08-06
LATEST ACTION
2022-03-04
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

ESOMEPRAZOLE STRONTIUM · ReferenceDiscontinued
ESOMEPRAZOLE STRONTIUM 24.65MG · CAPSULE, DELAYED RELEASE · ORAL
ESOMEPRAZOLE STRONTIUM · ReferenceDiscontinued
ESOMEPRAZOLE STRONTIUM 49.3MG · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2022-03-04Labeling · Supplement 7 · standard — Letter ↗AP
2020-11-27Labeling · Supplement 6 · standard — Label ↗AP
2018-06-07Labeling · Supplement 5 · standard — Label ↗AP
2016-10-24Labeling · Supplement 3 · standard — Letter ↗AP
2014-12-19Labeling · Supplement 2 · 901 required — Label ↗AP
2013-08-06Type 2 - New Active Ingredient · Original · standard — Review ↗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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