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FDA NDA · NDA208056

DEXILANT SOLUTAB

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA208056
TYPE
NDA
ORIGINAL APPROVAL
2016-01-26
LATEST ACTION
2016-10-24
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

DEXILANT SOLUTAB · ReferenceDiscontinued
DEXLANSOPRAZOLE 30MG · TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE · ORAL

Approval history

2016-10-24Labeling · Supplement 3 · standard — Letter ↗AP
2016-07-08Efficacy · Supplement 1 · standard — Label ↗AP
2016-01-26Type 3 - New Dosage Form · 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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