← FDA DRUG APPROVALS

FDA NDA · NDA021313

CLARINEX-D 12 HOUR

desloratadine and pseudoephedrine sulfate

Sponsor: ORGANON LLC

APPLICATION
NDA021313
TYPE
NDA
ORIGINAL APPROVAL
2006-02-01
LATEST ACTION
2019-03-15
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

CLARINEX-D 12 HOUR · ReferencePrescription
DESLORATADINE 2.5MG, PSEUDOEPHEDRINE SULFATE 120MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2019-03-15Labeling · Supplement 12 · standard — Letter ↗AP
2018-04-19Labeling · Supplement 10 · standard — Label ↗AP
2018-02-06Labeling · Supplement 9 · standard — Label ↗AP
2015-10-16Manufacturing (CMC) · Supplement 6 · standardAP
2014-03-07Labeling · Supplement 5 · standard — Label ↗AP
2009-12-30Labeling · Supplement 2 · standard — Letter ↗AP
2007-07-19Labeling · Supplement 1 · standard — Letter ↗AP
2006-02-01Type 5 - New Formulation or New Manufacturer · 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →