Nicoderm Cq

NDA 20165, held by Chattem Sanofi. Nicotine.

As of Nov 14, 2026, NDA 20165 (Nicoderm Cq), held by Chattem Sanofi, was first approved by FDA on Nov 7, 1991, with 29 approved supplements and 0 published complete response letters.

First approved: Nov 7, 1991
Review: Standard
Supplements approved: 29
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 30 submissions below


Aug 2, 1996	Supplement 11Efficacy (new indication or use) · Standard review	Approved	None posted
Nov 7, 1991	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms


Nicoderm Cq21MG/24HR · film, extended release;transdermal	Nicotine	OTCReference drug
Nicoderm Cq14MG/24HR · film, extended release;transdermal	Nicotine	OTCReference drug
Nicoderm Cq7MG/24HR · film, extended release;transdermal	Nicotine	OTCReference drug

All 30 submissions, including labeling and manufacturing supplements


Nov 6, 2024	Supplement 50Manufacturing	Approved	Label Letter
Mar 4, 2022	Supplement 47Labeling · Standard review	Approved	Label Letter
May 4, 2016	Supplement 38Labeling · Standard review	Approved	Label Letter
Oct 26, 2015	Supplement 37Manufacturing · Standard review	Approved	None posted
Oct 7, 2015	Supplement 36Labeling · Standard review	Approved	Label Letter
Aug 6, 2015	Supplement 35Labeling · Standard review	Approved	Letter Label
Feb 3, 2015	Supplement 34Labeling · Standard review	Approved	Label Letter
Apr 30, 2014	Supplement 29Labeling · Standard review	Approved	Label Letter
Feb 20, 2014	Supplement 26Manufacturing · Standard review	Approved	None posted
Oct 31, 2013	Supplement 31Labeling · Standard review	Approved	Label Letter
Sep 20, 2012	Supplement 28Labeling · Standard review	Approved	Letter
Apr 13, 2007	Supplement 24Labeling · Standard review	Approved	Letter Label
Sep 15, 2006	Supplement 23Labeling · Standard review	Approved	Letter Label
Aug 13, 2002	Supplement 20Labeling · Standard review	Approved	Review Letter
Jun 8, 2001	Supplement 19Labeling · Standard review	Approved	None posted
Sep 21, 2000	Supplement 18Manufacturing · Standard review	Approved	None posted
Feb 16, 2000	Supplement 17Manufacturing · Standard review	Approved	None posted
Feb 16, 2000	Supplement 16Labeling · Standard review	Approved	None posted
Sep 14, 1999	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 11, 1997	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 21, 1997	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 21, 1997	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 2, 1996	Supplement 11Efficacy (new indication or use) · Standard review	Approved	None posted
Jan 23, 1996	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 19, 1993	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 19, 1993	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 12, 1992	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 22, 1992	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 22, 1992	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 7, 1991	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20165
Drugs@FDA: Overview at FDA
Company: Chattem Sanofi

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