Relieves nicotine withdrawal symptoms. NDA 20385, held by Pfizer Inc. Nicotine.
As of Nov 13, 2026, NDA 20385 (Nicotrol), held by Pfizer Inc, was first approved by FDA on Mar 22, 1996, with 8 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE NICOTROL NS is indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms. NICOTROL NS therapy should be used as a part of a comprehensive behavioral smoking cessation program. The safety and efficacy of the continued use of NICOTROL NS for periods longer than 6 months have not been adequately studied and such use is not recommended.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 22, 1996 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nicotrol0.5MG/SPRAY · spray, metered;nasal | Nicotine | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 23, 2024 | Supplement 12Labeling · Standard review | Approved | |
| Aug 29, 2019 | Supplement 11Labeling · Standard review | Approved | |
| Jun 29, 2010 | Supplement 10Labeling | Approved | |
| Jul 16, 2004 | Supplement 7Labeling · Standard review | Approved | |
| Nov 6, 2003 | Supplement 6Labeling · Standard review | Approved | |
| Sep 8, 2002 | Supplement 5Labeling · Standard review | Approved | |
| Jul 9, 2001 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 14, 1998 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Mar 22, 1996 | Original applicationNew dosage form · Standard review | Approved | None posted |
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
