← FDA DRUG APPROVALS

FDA NDA · NDA020704

CLARITIN REDITABS

loratadine

Sponsor: BAYER HEALTHCARE LLC

APPLICATION
NDA020704
TYPE
NDA
ORIGINAL APPROVAL
1996-12-23
LATEST ACTION
2023-05-25
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Over-the-counter

Products

CLARITIN HIVES RELIEF REDITAB · ReferenceOver-the-counter
LORATADINE 10MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLARITIN REDITABS · ReferenceOver-the-counter
LORATADINE 10MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2023-05-25Labeling · Supplement 41 · standard — Letter ↗AP
2021-01-11Labeling · Supplement 37 · standard — Letter ↗AP
2019-05-07Labeling · Supplement 35 · standard — Letter ↗AP
2019-02-28Labeling · Supplement 34 · standard — Letter ↗AP
2018-07-23Labeling · Supplement 33 · standard — Letter ↗AP
2017-05-16Labeling · Supplement 32 · standard — Letter ↗AP
2016-11-04Labeling · Supplement 29 · standard — Letter ↗AP
2015-11-25Labeling · Supplement 28 · standard — Label ↗AP
2014-07-22Labeling · Supplement 27 · standard — Letter ↗AP
2009-01-29Manufacturing (CMC) · Supplement 21 — Letter ↗AP
2008-10-21Labeling · Supplement 20 · standard — Letter ↗AP
2006-01-19Manufacturing (CMC) · Supplement 14 · standard — Letter ↗AP
2003-11-19Efficacy · Supplement 9 · standard — Letter ↗AP
2002-11-27Efficacy · Supplement 8 · standard — Review ↗AP
2000-09-18Manufacturing (CMC) · Supplement 7 · standardAP
1998-10-29Manufacturing (CMC) · Supplement 4 · standard — Review ↗AP
1998-05-29Manufacturing (CMC) · Supplement 1 · standardAP
1998-01-23Manufacturing (CMC) · Supplement 3 · standard — Review ↗AP
1997-09-19Manufacturing (CMC) · Supplement 2 · standardAP
1996-12-23Type 3 - New Dosage Form · Original · standardAP
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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