← FDA DRUG APPROVALS

FDA NDA · NDA021330

NICORETTE

nicotine polacrilex

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA021330
TYPE
NDA
ORIGINAL APPROVAL
2002-10-31
LATEST ACTION
2024-09-06
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

2024-09-06Labeling · Supplement 26 · standard — Label ↗AP
2021-11-09Labeling · Supplement 24 · standard — Letter ↗AP
2018-08-10Manufacturing (CMC) · Supplement 21 — Letter ↗AP
2015-09-30Labeling · Supplement 19 · standard — Label ↗AP
2015-08-10Labeling · Supplement 20 · standard — Letter ↗AP
2015-05-18Labeling · Supplement 18 · standard — Label ↗AP
2014-08-14Labeling · Supplement 17 · standard — Letter ↗AP
2013-10-28Labeling · Supplement 16 · standard — Letter ↗AP
2013-08-07Labeling · Supplement 15 · standard — Letter ↗AP
2013-03-08Manufacturing (CMC) · Supplement 14 · standard — Review ↗AP
2012-05-23Efficacy · Supplement 13 · standard — Review ↗AP
2010-08-27Labeling · Supplement 9 · unknown — Letter ↗AP
2010-01-05Labeling · Supplement 8 · standard — Letter ↗AP
2008-05-23Manufacturing (CMC) · Supplement 7 — Review ↗AP
2006-09-01Manufacturing (CMC) · Supplement 5 — Letter ↗AP
2005-11-22Manufacturing (CMC) · Supplement 4 · standard — Review ↗AP
2005-10-25Manufacturing (CMC) · Supplement 3 · standard — Label ↗AP
2004-02-13Manufacturing (CMC) · Supplement 2 · standard — Letter ↗AP
2002-10-31Type 3 - New Dosage Form · Original · standard — Letter ↗AP
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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