Nicotrol

NDA 20536, held by Mcneil Cons. Nicotine.

As of Nov 13, 2026, NDA 20536 (Nicotrol), held by Mcneil Cons, was first approved by FDA on Jul 3, 1996, with 7 approved supplements and 0 published complete response letters.

First approved: Jul 3, 1996
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jul 3, 1996	Original applicationTYPE 8 · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nicotrol15MG/16HR · film, extended release;transdermal	Nicotine	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Jul 23, 2002	Supplement 10Labeling · Standard review	Approved	Letter
Sep 1, 2000	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 26, 1999	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 26, 1999	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 18, 1998	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 11, 1997	Supplement 2Labeling · Standard review	Approved	None posted
Apr 1, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 3, 1996	Original applicationTYPE 8 · Standard review	Approved	None posted

Identifiers

Application: NDA 20536
Drugs@FDA: Overview at FDA
Company: Mcneil Cons

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