← FDA DRUG APPROVALS

FDA NDA · NDA021312

CLARINEX

Sponsor: ORGANON

APPLICATION
NDA021312
TYPE
NDA
ORIGINAL APPROVAL
2002-06-26
LATEST ACTION
2019-03-15
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

CLARINEX · ReferenceDiscontinued
DESLORATADINE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
CLARINEX · ReferenceDiscontinued
DESLORATADINE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2019-03-15Labeling · Supplement 20 · standard — Letter ↗AP
2019-03-01Labeling · Supplement 18 · standard — Label ↗AP
2014-04-23Labeling · Supplement 15 · standard — Letter ↗AP
2012-11-14Manufacturing (CMC) · Supplement 14 · standardAP
2010-12-22Labeling · Supplement 11 · standard — Letter ↗AP
2006-12-14Labeling · Supplement 9 · standard — Letter ↗AP
2006-12-14Labeling · Supplement 8 · standard — Letter ↗AP
2006-12-14Labeling · Supplement 6 · standard — Label ↗AP
2005-07-14Manufacturing (CMC) · Supplement 7 · standard — Letter ↗AP
2004-01-29Labeling · Supplement 4 · standard — Letter ↗AP
2003-02-06Labeling · Supplement 2 · standard — Letter ↗AP
2002-06-26Type 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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