Nicorette

NDA 21330, held by Haleon US Holdings. Nicotine Polacrilex.

As of Nov 14, 2026, NDA 21330 (Nicorette), held by Haleon US Holdings, was first approved by FDA on Oct 31, 2002, with 18 approved supplements and 0 published complete response letters.

First approved: Oct 31, 2002
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


May 23, 2012	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Review Letter
Oct 31, 2002	Original applicationNew dosage form · Standard review	Approved	Review Letter

Products

2 strengths and forms


NicoretteEQ 2MG BASE · troche/lozenge;oral	Nicotine Polacrilex	OTCReference drug
NicoretteEQ 4MG BASE · troche/lozenge;oral	Nicotine Polacrilex	OTCReference drug

All 19 submissions, including labeling and manufacturing supplements


Sep 6, 2024	Supplement 26Labeling · Standard review	Approved	Label Letter
Nov 9, 2021	Supplement 24Labeling · Standard review	Approved	Label Letter
Aug 10, 2018	Supplement 21Manufacturing	Approved	Review Letter Label
Sep 30, 2015	Supplement 19Labeling · Standard review	Approved	Label Letter
Aug 10, 2015	Supplement 20Labeling · Standard review	Approved	Letter Label
May 18, 2015	Supplement 18Labeling · Standard review	Approved	Label Letter
Aug 14, 2014	Supplement 17Labeling · Standard review	Approved	Label Letter
Oct 28, 2013	Supplement 16Labeling · Standard review	Approved	Label Letter
Aug 7, 2013	Supplement 15Labeling · Standard review	Approved	Letter
Mar 8, 2013	Supplement 14Manufacturing · Standard review	Approved	Review
May 23, 2012	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Review Letter
Aug 27, 2010	Supplement 9Labeling	Approved	Letter
Jan 5, 2010	Supplement 8Labeling · Standard review	Approved	Letter
May 23, 2008	Supplement 7Manufacturing	Approved	Review Letter
Sep 1, 2006	Supplement 5Manufacturing	Approved	Letter Label
Nov 22, 2005	Supplement 4Manufacturing · Standard review	Approved	Review Letter Label
Oct 25, 2005	Supplement 3Manufacturing · Standard review	Approved	Label Letter
Feb 13, 2004	Supplement 2Manufacturing · Standard review	Approved	Review Label Letter
Oct 31, 2002	Original applicationNew dosage form · Standard review	Approved	Review Letter

Identifiers

Application: NDA 21330
Drugs@FDA: Overview at FDA
Company: Haleon US Holdings

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters