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FDA NDA · NDA021605

CLARINEX D 24 HOUR

Sponsor: ORGANON

APPLICATION
NDA021605
TYPE
NDA
ORIGINAL APPROVAL
2005-03-03
LATEST ACTION
2019-03-15
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

CLARINEX D 24 HOUR · ReferenceDiscontinued
DESLORATADINE 5MG, PSEUDOEPHEDRINE SULFATE 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2019-03-15Labeling · Supplement 17 · standard — Letter ↗AP
2018-04-19Labeling · Supplement 13 · standard — Label ↗AP
2018-02-28Labeling · Supplement 15 · standard — Letter ↗AP
2014-03-07Labeling · Supplement 12 · standard — Letter ↗AP
2009-12-30Labeling · Supplement 6 · standard — Letter ↗AP
2005-03-03Type 3 - New Dosage Form · Original · standard — Label ↗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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