← FDA DRUG APPROVALS

FDA NDA · NDA020641

CLARITIN ALLERGY

loratadine

Sponsor: BAYER HEALTHCARE LLC

APPLICATION
NDA020641
TYPE
NDA
ORIGINAL APPROVAL
1996-10-10
LATEST ACTION
2024-05-22
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued, Over-the-counter

Products

CLARITIN HIVES RELIEF · ReferenceDiscontinued
LORATADINE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SYRUP · ORAL
CLARITIN · ReferenceOver-the-counter
LORATADINE 1MG/ML · SYRUP · ORAL

Approval history

2024-05-22Manufacturing (CMC) · Supplement 48 — Label ↗AP
2019-02-28Labeling · Supplement 46 · standard — Letter ↗AP
2018-05-14Labeling · Supplement 45 · standard — Letter ↗AP
2016-08-09Labeling · Supplement 42 · standard — Letter ↗AP
2016-02-12Manufacturing (CMC) · Supplement 41 · standardAP
2015-12-30Labeling · Supplement 40 · standard — Label ↗AP
2015-12-10Manufacturing (CMC) · Supplement 39 · standardAP
2015-11-12Labeling · Supplement 38 · standard — Letter ↗AP
2015-10-21Manufacturing (CMC) · Supplement 37 — Letter ↗AP
2015-04-16Manufacturing (CMC) · Supplement 36 · standard — Label ↗AP
2014-05-15Manufacturing (CMC) · Supplement 35 · standardAP
2013-04-16Manufacturing (CMC) · Supplement 33 · standardAP
2013-02-28Manufacturing (CMC) · Supplement 32 · standard — Letter ↗AP
2012-11-20Manufacturing (CMC) · Supplement 30 · standardAP
2008-07-25Manufacturing (CMC) · Supplement 24 — Letter ↗AP
2008-07-25Labeling · Supplement 25 · standard — Letter ↗AP
2005-06-14Manufacturing (CMC) · Supplement 18 · standard — Letter ↗AP
2004-10-27Manufacturing (CMC) · Supplement 17 · standard — Letter ↗AP
2004-07-15Manufacturing (CMC) · Supplement 16 · standard — Letter ↗AP
2003-11-19Efficacy · Supplement 11 · standard — Letter ↗AP
2002-12-09Manufacturing (CMC) · Supplement 12 · standardAP
2002-11-27Efficacy · Supplement 9 · standard — Review ↗AP
2002-07-23Manufacturing (CMC) · Supplement 10 · standardAP
2000-12-04Efficacy · Supplement 7 · standard — Label ↗AP
1999-01-07Manufacturing (CMC) · Supplement 6 · standardAP
1998-10-29Manufacturing (CMC) · Supplement 3 · standard — Review ↗AP
1998-03-30Labeling · Supplement 2 · standardAP
1998-01-23Manufacturing (CMC) · Supplement 1 · standard — Review ↗AP
1996-10-10Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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