← FDA DRUG APPROVALS

FDA NDA · NDA022360

NICORETTE

nicotine polacrilex

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA022360
TYPE
NDA
ORIGINAL APPROVAL
2009-05-18
LATEST ACTION
2025-03-17
ROUTE
ORAL
DOSAGE FORM
TROCHE/LOZENGE
MARKETING STATUS
Over-the-counter

Products

NICORETTE · ReferenceOver-the-counter
NICOTINE POLACRILEX EQ 2MG BASE · TROCHE/LOZENGE · ORAL
NICORETTE · ReferenceOver-the-counter
NICOTINE POLACRILEX EQ 4MG BASE · TROCHE/LOZENGE · ORAL

Approval history

2025-03-17Manufacturing (CMC) · Supplement 19 — Label ↗AP
2024-11-21Manufacturing (CMC) · Supplement 18 — Label ↗AP
2024-04-30Labeling · Supplement 17 · standard — Letter ↗AP
2021-03-05Manufacturing (CMC) · Supplement 12 — Letter ↗AP
2018-06-05Labeling · Supplement 11 · standard — Letter ↗AP
2015-09-30Labeling · Supplement 10 · standard — Label ↗AP
2015-04-16Labeling · Supplement 9 · standard — Label ↗AP
2014-02-14Manufacturing (CMC) · Supplement 8 · standard — Review ↗AP
2013-10-28Labeling · Supplement 7 · standard — Label ↗AP
2013-05-23Labeling · Supplement 6 · standard — Letter ↗AP
2013-03-08UNKNOWN · Supplement 5 · standard — Review ↗AP
2012-09-18Labeling · Supplement 4 · standard — Label ↗AP
2011-12-06Labeling · Supplement 2 · unknown — Letter ↗AP
2009-12-21Manufacturing (CMC) · Supplement 1AP
2009-05-18Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗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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