ANDA 76258, held by Mylan Technologies. Fentanyl.
As of Nov 13, 2026, ANDA 76258 (Fentanyl-25, Fentanyl-50, Fentanyl-75), held by Mylan Technologies, was first approved by FDA on Jan 28, 2005, with 28 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 |
|---|---|---|---|
| Jan 28, 2005 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| 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 |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 18, 2026 | Supplement 53REMS | Approved | None posted |
| Dec 22, 2025 | Supplement 52Labeling · Standard review | Approved | None posted |
| Dec 22, 2025 | Supplement 51Labeling · Standard review | Approved | None posted |
| Dec 22, 2025 | Supplement 48Labeling · Standard review | Approved | None posted |
| Oct 31, 2024 | Supplement 49REMS | Approved | None posted |
| Dec 15, 2023 | Supplement 46Labeling · Standard review | Approved | None posted |
| Dec 14, 2023 | Supplement 43Labeling · Standard review | Approved | None posted |
| Dec 14, 2023 | Supplement 40Labeling · Standard review | Approved | None posted |
| Dec 14, 2023 | Supplement 39Labeling · Standard review | Approved | None posted |
| Dec 14, 2023 | Supplement 38Labeling · Standard review | Approved | None posted |
| Dec 14, 2023 | Supplement 34Labeling · Standard review | Approved | None posted |
| Sep 18, 2018 | Supplement 37REMS | Approved | None posted |
| May 26, 2017 | Supplement 35REMS | Approved | None posted |
| Sep 30, 2016 | Supplement 33REMS | Approved | None posted |
| Apr 20, 2016 | Supplement 32REMS | Approved | None posted |
| Jul 8, 2015 | Supplement 27Manufacturing | Approved | None posted |
| Jun 26, 2015 | Supplement 31REMS | Approved | None posted |
| Aug 19, 2014 | Supplement 30REMS | Approved | None posted |
| Jun 20, 2014 | Supplement 28Labeling · Standard review | Approved | None posted |
| Apr 15, 2013 | Supplement 22REMS | Approved | None posted |
| Jul 10, 2012 | Supplement 18Labeling | Approved | None posted |
| Jul 9, 2012 | Supplement 21Labeling | Approved | None posted |
| Jul 9, 2012 | Supplement 19REMS | Approved | None posted |
| May 20, 2008 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jan 23, 2007 | Supplement 6Labeling | Approved | None posted |
| Jan 23, 2007 | Supplement 5Manufacturing | Approved | None posted |
| Sep 6, 2005 | Supplement 7Labeling | Approved | None posted |
| May 4, 2005 | Supplement 2Labeling | Approved | None posted |
| Jan 28, 2005 | 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