ANDA 76709, held by Actavis Labs Ut Inc. Fentanyl.
As of Nov 13, 2026, ANDA 76709 (Fentanyl-25, Fentanyl-50, Fentanyl-75), held by Actavis Labs Ut Inc, was first approved by FDA on Aug 20, 2007, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 20, 2007 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fentanyl-2525MCG/HR · film, extended release;transdermal | Fentanyl | Discontinued |
| Fentanyl-5050MCG/HR · film, extended release;transdermal | Fentanyl | Discontinued |
| Fentanyl-7575MCG/HR · film, extended release;transdermal | Fentanyl | Discontinued |
| Fentanyl-100100MCG/HR · film, extended release;transdermal | Fentanyl | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 18, 2018 | Supplement 31REMS | Approved | None posted |
| May 26, 2017 | Supplement 28REMS | Approved | None posted |
| Sep 30, 2016 | Supplement 27REMS | Approved | None posted |
| Apr 20, 2016 | Supplement 26REMS | Approved | None posted |
| Jun 26, 2015 | Supplement 25REMS | Approved | None posted |
| Sep 5, 2014 | Supplement 21Manufacturing | Approved | None posted |
| Aug 19, 2014 | Supplement 24REMS | Approved | None posted |
| Jun 20, 2014 | Supplement 22Labeling · Standard review | Approved | None posted |
| Apr 15, 2013 | Supplement 18REMS | Approved | None posted |
| Jul 27, 2012 | Supplement 15Labeling | Approved | None posted |
| Jul 9, 2012 | Supplement 12REMS | Approved | None posted |
| Dec 2, 2011 | Supplement 13Labeling | Approved | None posted |
| Dec 17, 2007 | Supplement 1Labeling | Approved | None posted |
| Aug 20, 2007 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
