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FDA NDA · NDA021300

CLARINEX

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APPLICATION
NDA021300
TYPE
NDA
ORIGINAL APPROVAL
2004-09-01
LATEST ACTION
2019-03-15
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

CLARINEX · ReferenceDiscontinued
DESLORATADINE 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL

Approval history

2019-03-15Labeling · Supplement 19 · standard — Letter ↗AP
2019-03-01Labeling · Supplement 17 · standard — Label ↗AP
2014-04-23Labeling · Supplement 14 · standard — Letter ↗AP
2010-12-22Labeling · Supplement 11 · standard — Letter ↗AP
2006-12-14Labeling · Supplement 3 · standard — Letter ↗AP
2006-12-14Labeling · Supplement 1 · standard — Letter ↗AP
2006-12-14Labeling · Supplement 4 · standardAP
2006-12-14Labeling · Supplement 5 · standard — Letter ↗AP
2004-09-01Type 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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