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FDA NDA · NDA021952

CLARITIN

Sponsor: BAYER HEALTHCARE LLC

APPLICATION
NDA021952
TYPE
NDA
ORIGINAL APPROVAL
2008-06-16
LATEST ACTION
2025-05-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Over-the-counter

Products

CLARITIN · ReferenceOver-the-counter
LORATADINE 10MG · CAPSULE · ORAL

Approval history

2025-05-09Manufacturing (CMC) · Supplement 24 — Label ↗AP
2023-05-31Labeling · Supplement 22 · standard — Label ↗AP
2018-12-21Labeling · Supplement 18 · standard — Label ↗AP
2018-07-20Labeling · Supplement 17 · standard — Letter ↗AP
2018-06-20Labeling · Supplement 16 · standard — Letter ↗AP
2018-06-04Labeling · Supplement 15 · standard — Letter ↗AP
2018-04-18Labeling · Supplement 14 · standard — Letter ↗AP
2015-12-09Labeling · Supplement 12 · standard — Letter ↗AP
2009-04-06Labeling · Supplement 3 · standard — Letter ↗AP
2008-06-16Type 3 - New Dosage Form · Original · standard — Review ↗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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