Nicorette

NDA 22360, held by Haleon US Holdings. Nicotine Polacrilex.

As of Nov 13, 2026, NDA 22360 (Nicorette), held by Haleon US Holdings, was first approved by FDA on May 18, 2009, with 14 approved supplements and 0 published complete response letters.

First approved: May 18, 2009
Review: Standard
Supplements approved: 14
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 15 submissions below

Date	Submission	Status	Documents
May 18, 2009	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter

Products

2 strengths and forms

Product	Active ingredient	Marketing
NicoretteEQ 2MG BASE · troche/lozenge;oral	Nicotine Polacrilex	OTCReference drug
NicoretteEQ 4MG BASE · troche/lozenge;oral	Nicotine Polacrilex	OTCReference drug

All 15 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 17, 2025	Supplement 19Manufacturing	Approved	Label Letter
Nov 21, 2024	Supplement 18Manufacturing	Approved	Label Letter
Apr 30, 2024	Supplement 17Labeling · Standard review	Approved	Letter Label
Mar 5, 2021	Supplement 12Manufacturing	Approved	Letter Label
Jun 5, 2018	Supplement 11Labeling · Standard review	Approved	Label Letter
Sep 30, 2015	Supplement 10Labeling · Standard review	Approved	Label Letter
Apr 16, 2015	Supplement 9Labeling · Standard review	Approved	Label Letter
Feb 14, 2014	Supplement 8Manufacturing · Standard review	Approved	Review
Oct 28, 2013	Supplement 7Labeling · Standard review	Approved	Label Letter
May 23, 2013	Supplement 6Labeling · Standard review	Approved	Label Letter
Mar 8, 2013	Supplement 5	Approved	Review
Sep 18, 2012	Supplement 4Labeling · Standard review	Approved	Label Letter
Dec 6, 2011	Supplement 2Labeling	Approved	Letter
Dec 21, 2009	Supplement 1Manufacturing	Approved	None posted
May 18, 2009	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter

Identifiers

Application: NDA 22360
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