← FDA DRUG APPROVALS

FDA NDA · NDA021165

CLARINEX

desloratadine

Sponsor: ORGANON

APPLICATION
NDA021165
TYPE
NDA
ORIGINAL APPROVAL
2001-12-21
LATEST ACTION
2019-03-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CLARINEX · ReferencePrescription
DESLORATADINE 5MG · TABLET · ORAL

Approval history

2019-03-15Labeling · Supplement 22 · standard — Letter ↗AP
2019-03-01Labeling · Supplement 20 · standard — Label ↗AP
2016-06-16Manufacturing (CMC) · Supplement 18 · standardAP
2016-06-16Manufacturing (CMC) · Supplement 19 · standardAP
2014-04-23Labeling · Supplement 17 · standard — Label ↗AP
2013-07-23Manufacturing (CMC) · Supplement 16 · standardAP
2010-12-22Labeling · Supplement 14 · standard — Letter ↗AP
2006-12-14Labeling · Supplement 7 · standard — Letter ↗AP
2006-12-14Labeling · Supplement 8 · standard — Letter ↗AP
2006-12-14Labeling · Supplement 9 · standard — Letter ↗AP
2004-01-29Labeling · Supplement 6 · standard — Letter ↗AP
2002-02-08Labeling · Supplement 1 · standard — Label ↗AP
2001-12-21Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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