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FDA NDA · NDA021563

CLARINEX

Sponsor: SCHERING

APPLICATION
NDA021563
TYPE
NDA
ORIGINAL APPROVAL
2004-09-01
LATEST ACTION
2019-03-15
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription

Products

CLARINEXPrescription
DESLORATADINE 0.5MG/ML · SYRUP · ORAL

Approval history

2019-03-15Labeling · Supplement 8 · standard — Letter ↗AP
2019-03-01Labeling · Supplement 6 · standard — Label ↗AP
2014-04-23Labeling · Supplement 3 · standard — Letter ↗AP
2010-12-22Labeling · Supplement 1 · standard — Letter ↗AP
2004-09-01Type 3 - New Dosage Form · Original · priority — 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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