← FDA DRUG APPROVALS

FDA NDA · NDA019658

CLARITIN

loratadine

Sponsor: BAYER HEALTHCARE LLC

APPLICATION
NDA019658
TYPE
NDA
ORIGINAL APPROVAL
1993-04-12
LATEST ACTION
2025-04-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

CLARITIN · ReferenceOver-the-counter
LORATADINE 10MG · TABLET · ORAL
CLARITIN HIVES RELIEF · ReferenceOver-the-counter
LORATADINE 10MG · TABLET · ORAL

Approval history

2025-04-17Labeling · Supplement 62 · standard — Letter ↗AP
2019-02-06Labeling · Supplement 56 · standard — Letter ↗AP
2018-12-21Labeling · Supplement 55 · standard — Label ↗AP
2018-10-03Labeling · Supplement 54 · standard — Letter ↗AP
2018-07-05Labeling · Supplement 53 · standard — Label ↗AP
2018-05-30Labeling · Supplement 52 · standard — Letter ↗AP
2018-05-30Labeling · Supplement 51 · standard — Letter ↗AP
2018-01-12Manufacturing (CMC) · Supplement 50AP
2017-04-26Labeling · Supplement 48 · standard — Label ↗AP
2016-12-14Labeling · Supplement 46 · standard — Letter ↗AP
2016-08-09Labeling · Supplement 45 · standard — Letter ↗AP
2015-12-18Labeling · Supplement 44 · standard — Label ↗AP
2015-09-14Manufacturing (CMC) · Supplement 43 · standardAP
2013-06-05Manufacturing (CMC) · Supplement 40 · standardAP
2012-11-16Manufacturing (CMC) · Supplement 39 · standardAP
2007-12-20Labeling · Supplement 26 · standard — Letter ↗AP
2003-11-19Efficacy · Supplement 20 · standard — Letter ↗AP
2003-06-25Labeling · Supplement 21 · standard — Letter ↗AP
2002-12-10Manufacturing (CMC) · Supplement 19 · standardAP
2002-11-27Efficacy · Supplement 18 · standard — Letter ↗AP
1999-07-23Manufacturing (CMC) · Supplement 16 · standardAP
1999-01-27Manufacturing (CMC) · Supplement 13 · standardAP
1998-10-29Manufacturing (CMC) · Supplement 14 · standard — Review ↗AP
1998-05-08Manufacturing (CMC) · Supplement 12 · standardAP
1998-01-27Labeling · Supplement 9 · standardAP
1998-01-23Manufacturing (CMC) · Supplement 10 · standard — Review ↗AP
1997-07-14Labeling · Supplement 8 · standardAP
1996-09-12Labeling · Supplement 1 · standardAP
1995-10-12Labeling · Supplement 5 · standard — Review ↗AP
1995-09-20Efficacy · Supplement 3 · standardAP
1995-09-01Manufacturing (CMC) · Supplement 6 · standardAP
1995-02-09Manufacturing (CMC) · Supplement 4 · standardAP
1993-09-17Labeling · Supplement 2 · standardAP
1993-04-12Type 1 - New Molecular Entity · Original · standardAP
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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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