ANDA 74612, held by Difgen Pharms. Nicotine.
As of Nov 13, 2026, ANDA 74612 (Nicotine), held by Difgen Pharms, was first approved by FDA on Oct 20, 1997, with 10 approved supplements and 0 published complete response letters.
Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 20, 1997 | Original application | Approved | None posted |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 13, 2015 | Supplement 25Labeling · Standard review | Approved | None posted |
| Feb 16, 2010 | Supplement 16Labeling | Approved | None posted |
| Oct 30, 2007 | Supplement 7Labeling | Approved | None posted |
| Feb 27, 2002 | Supplement 8Manufacturing | Approved | None posted |
| Feb 15, 2000 | Supplement 5Manufacturing | Approved | None posted |
| Feb 15, 2000 | Supplement 6Manufacturing | Approved | None posted |
| May 24, 1999 | Supplement 1Manufacturing | Approved | None posted |
| May 24, 1999 | Supplement 2Manufacturing | Approved | None posted |
| May 24, 1999 | Supplement 3Manufacturing | Approved | None posted |
| May 24, 1999 | Supplement 4Manufacturing | Approved | None posted |
| Oct 20, 1997 | Original application | 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
