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FDA NDA · NDA021993

CLARITIN REDITABS

loratadine

Sponsor: BAYER HEALTHCARE LLC

APPLICATION
NDA021993
TYPE
NDA
ORIGINAL APPROVAL
2006-12-12
LATEST ACTION
2023-05-25
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Over-the-counter

Products

CLARITIN REDITABS · ReferenceOver-the-counter
LORATADINE 5MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2023-05-25Labeling · Supplement 23 · standard — Letter ↗AP
2019-02-28Labeling · Supplement 17 · standard — Letter ↗AP
2018-07-23Labeling · Supplement 16 · standard — Letter ↗AP
2015-11-25Labeling · Supplement 13 · standard — Label ↗AP
2014-07-22Labeling · Supplement 12 · standard — Label ↗AP
2008-10-21Labeling · Supplement 4 · standard — Letter ↗AP
2006-12-12Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
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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