ANDA 77449, held by Difgen Pharms. Fentanyl.
As of Nov 14, 2026, ANDA 77449 (Fentanyl-25, Fentanyl-50, Fentanyl-75), held by Difgen Pharms, was first approved by FDA on Oct 20, 2008, with 25 approved supplements and 0 published complete response letters.
Fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid-tolerant patients, that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 20, 2008 | Original application | Approved |
| Fentanyl-2525MCG/HR · film, extended release;transdermal | Fentanyl | Rx |
| Fentanyl-5050MCG/HR · film, extended release;transdermal | Fentanyl | Rx |
| Fentanyl-7575MCG/HR · film, extended release;transdermal | Fentanyl | Rx |
| Fentanyl-100100MCG/HR · film, extended release;transdermal | Fentanyl | Rx |
| Fentanyl-1212.5MCG/HR · film, extended release;transdermal | Fentanyl | Rx |
| Fentanyl-3737.5MCG/HR · film, extended release;transdermal | Fentanyl | Rx |
| Fentanyl-6262.5MCG/HR · film, extended release;transdermal | Fentanyl | Rx |
| Fentanyl-8787.5MCG/HR · film, extended release;transdermal | Fentanyl | Rx |
| Jun 18, 2026 | Supplement 45REMS | Approved | None posted |
| Dec 22, 2025 | Supplement 44Labeling · Standard review | Approved | None posted |
| Dec 22, 2025 | Supplement 42Labeling · Standard review | Approved | None posted |
| Oct 31, 2024 | Supplement 41REMS | Approved | None posted |
| Dec 15, 2023 | Supplement 40Labeling · Standard review | Approved | None posted |
| Dec 15, 2023 | Supplement 39Labeling · Standard review | Approved | None posted |
| Dec 13, 2023 | Supplement 35Labeling · Standard review | Approved | None posted |
| Dec 13, 2023 | Supplement 31Labeling · Standard review | Approved | None posted |
| Dec 13, 2023 | Supplement 28Labeling · Standard review | Approved | None posted |
| Dec 13, 2023 | Supplement 27Labeling · Standard review | Approved | None posted |
| Sep 18, 2018 | Supplement 26REMS | Approved | None posted |
| Aug 10, 2017 | Supplement 25Manufacturing | Approved | None posted |
| Aug 10, 2017 | Supplement 22Labeling · Standard review | Approved | None posted |
| May 26, 2017 | Supplement 24REMS | Approved | None posted |
| Sep 30, 2016 | Supplement 20REMS | Approved | None posted |
| Aug 22, 2016 | Supplement 19Manufacturing | Approved | None posted |
| Apr 20, 2016 | Supplement 18REMS | Approved | None posted |
| Sep 11, 2015 | Supplement 16 | Approved | None posted |
| Jun 26, 2015 | Supplement 15REMS | Approved | None posted |
| Aug 19, 2014 | Supplement 11REMS | Approved | None posted |
| Jul 23, 2014 | Supplement 10Labeling · Standard review | Approved | None posted |
| Apr 19, 2013 | Supplement 5REMS | Approved | None posted |
| Mar 7, 2013 | Supplement 4Labeling · Standard review | Approved | None posted |
| Feb 14, 2013 | Supplement 3REMS | Approved | None posted |
| Mar 2, 2009 | Supplement 1Labeling | Approved | None posted |
| Oct 20, 2008 | Original application | Approved |
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