← FDA DRUG APPROVALS

FDA NDA · NDA020066

NICORETTE 4MG FRUIT CHILL GUM, LIL DRUG STORE

nicotine polacrilex

Sponsor: HALEON US HOLDINGS

APPLICATION
NDA020066
TYPE
NDA
ORIGINAL APPROVAL
1992-06-08
LATEST ACTION
2024-01-03
ROUTE
BUCCAL, ORAL
DOSAGE FORM
GUM, CHEWING
MARKETING STATUS
Over-the-counter

Products

NICORETTE · ReferenceOver-the-counter
NICOTINE POLACRILEX EQ 4MG BASE · GUM, CHEWING · BUCCAL
NICORETTE · ReferenceOver-the-counter
NICOTINE POLACRILEX EQ 4MG BASE · GUM, CHEWING · BUCCAL
NICORETTE (MINT) · ReferenceOver-the-counter
NICOTINE POLACRILEX EQ 4MG BASE · GUM, CHEWING · BUCCAL

Approval history

2024-01-03Labeling · Supplement 66 · standard — Label ↗AP
2021-04-23Labeling · Supplement 65 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 64 · standard — Letter ↗AP
2018-11-14Labeling · Supplement 62 · standard — Label ↗AP
2018-06-05Labeling · Supplement 61 · standard — Letter ↗AP
2017-12-11Labeling · Supplement 60 · standard — Letter ↗AP
2017-09-11Manufacturing (CMC) · Supplement 59 — Label ↗AP
2015-09-30Labeling · Supplement 57 · standard — Letter ↗AP
2014-10-30Labeling · Supplement 55 · standard — Letter ↗AP
2014-06-11Labeling · Supplement 54 · standard — Label ↗AP
2014-06-11Labeling · Supplement 53 · standard — Letter ↗AP
2014-04-17Manufacturing (CMC) · Supplement 51 · standardAP
2013-10-30Labeling · Supplement 49 · standard — Label ↗AP
2012-08-01Manufacturing (CMC) · Supplement 48 · standardAP
2012-07-16Labeling · Supplement 46 · standard — Label ↗AP
2012-02-15Labeling · Supplement 42 · standard — Label ↗AP
2012-02-01Labeling · Supplement 41 · standard — Letter ↗AP
2011-09-27Labeling · Supplement 38 · standard — Letter ↗AP
2011-05-17Labeling · Supplement 37 · standard — Letter ↗AP
2010-04-21Manufacturing (CMC) · Supplement 32AP
2009-05-06Efficacy · Supplement 33 · unknown — Letter ↗AP
2008-06-13Manufacturing (CMC) · Supplement 31 — Review ↗AP
2007-06-26Manufacturing (CMC) · Supplement 30 — Letter ↗AP
2006-05-04Manufacturing (CMC) · Supplement 24 — Letter ↗AP
2005-12-02Manufacturing (CMC) · Supplement 23 · standard — Letter ↗AP
2004-06-23Labeling · Supplement 17 · standard — Letter ↗AP
2004-06-18Manufacturing (CMC) · Supplement 19 · standard — Letter ↗AP
2004-04-23Manufacturing (CMC) · Supplement 16 · standard — Review ↗AP
2002-11-15Manufacturing (CMC) · Supplement 14 · standardAP
2002-08-09Labeling · Supplement 13 · standard — Letter ↗AP
2001-08-24Labeling · Supplement 8 · standardAP
2000-09-25Manufacturing (CMC) · Supplement 10 · standard — Label ↗AP
1998-12-23Efficacy · Supplement 7 · unknown — Review ↗AP
1998-11-04Manufacturing (CMC) · Supplement 6 · standardAP
1996-02-09Efficacy · Supplement 4 · standardAP
1993-03-22Manufacturing (CMC) · Supplement 3 · standardAP
1993-03-22Manufacturing (CMC) · Supplement 1 · standardAP
1992-06-08Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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