← FDA DRUG APPROVALS

FDA NDA · NDA018612

NICORETTE ORIGINAL

nicotine polacrilex

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA018612
TYPE
NDA
ORIGINAL APPROVAL
1984-01-13
LATEST ACTION
2024-01-03
ROUTE
ORAL, BUCCAL
DOSAGE FORM
GUM, CHEWING
MARKETING STATUS
Over-the-counter

Products

NICORETTE · ReferenceOver-the-counter
NICOTINE POLACRILEX EQ 2MG BASE · GUM, CHEWING · BUCCAL
NICORETTE · ReferenceOver-the-counter
NICOTINE POLACRILEX EQ 2MG BASE · GUM, CHEWING · BUCCAL
NICORETTE (MINT) · ReferenceOver-the-counter
NICOTINE POLACRILEX EQ 2MG BASE · GUM, CHEWING · BUCCAL

Approval history

2024-01-03Labeling · Supplement 84 · standard — Label ↗AP
2021-04-23Labeling · Supplement 83 · standard — Letter ↗AP
2018-11-14Labeling · Supplement 81 · standard — Label ↗AP
2018-06-05Labeling · Supplement 80 · standard — Letter ↗AP
2017-12-11Labeling · Supplement 79 · standard — Letter ↗AP
2017-09-11Manufacturing (CMC) · Supplement 78 — Label ↗AP
2015-09-30Labeling · Supplement 76 · standard — Letter ↗AP
2015-09-10Manufacturing (CMC) · Supplement 77 · priorityAP
2015-01-05Manufacturing (CMC) · Supplement 75 · priorityAP
2014-10-30Labeling · Supplement 74 · standard — Label ↗AP
2014-06-11Labeling · Supplement 73 · standard — Letter ↗AP
2014-06-11Labeling · Supplement 72 · standard — Letter ↗AP
2014-04-17Manufacturing (CMC) · Supplement 70 · priorityAP
2014-02-21Manufacturing (CMC) · Supplement 71 · priorityAP
2013-10-30Labeling · Supplement 68 · standard — Letter ↗AP
2013-10-11Manufacturing (CMC) · Supplement 69 · priorityAP
2012-08-01Manufacturing (CMC) · Supplement 67 · priorityAP
2012-07-16Labeling · Supplement 65 · standard — Letter ↗AP
2012-02-15Labeling · Supplement 61 · standard — Letter ↗AP
2012-02-01Labeling · Supplement 60 · standard — Letter ↗AP
2011-09-27Labeling · Supplement 57 · standard — Letter ↗AP
2011-09-12Manufacturing (CMC) · Supplement 58 · priorityAP
2011-05-17Labeling · Supplement 56 · standard — Letter ↗AP
2010-04-21Manufacturing (CMC) · Supplement 51AP
2009-05-06Efficacy · Supplement 52 · unknown — Letter ↗AP
2008-06-13Manufacturing (CMC) · Supplement 50 — Letter ↗AP
2007-06-26Manufacturing (CMC) · Supplement 49 — Letter ↗AP
2006-05-04Manufacturing (CMC) · Supplement 43 — Letter ↗AP
2005-12-02Manufacturing (CMC) · Supplement 42 · priority — Letter ↗AP
2004-06-23Labeling · Supplement 35 · standard — Letter ↗AP
2004-06-18Manufacturing (CMC) · Supplement 37 · priority — Letter ↗AP
2004-04-23Manufacturing (CMC) · Supplement 34 · priority — Letter ↗AP
2002-11-15Manufacturing (CMC) · Supplement 32 · priorityAP
2002-08-09Labeling · Supplement 31 · standard — Letter ↗AP
2001-08-24Labeling · Supplement 26 · standardAP
2000-09-25Manufacturing (CMC) · Supplement 28 · priorityAP
1998-12-23Efficacy · Supplement 25 — Letter ↗AP
1998-11-04Manufacturing (CMC) · Supplement 24 · priorityAP
1996-02-09Efficacy · Supplement 22 · standard — Review ↗AP
1991-08-22Manufacturing (CMC) · Supplement 16 · priorityAP
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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