ANDA 77154, held by Specgx LLC. Fentanyl.
As of Nov 14, 2026, ANDA 77154 (Fentanyl-25, Fentanyl-50, Fentanyl-75), held by Specgx LLC, was first approved by FDA on Feb 9, 2011, with 23 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 |
|---|---|---|---|
| Feb 9, 2011 | 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 |
| Jun 18, 2026 | Supplement 41REMS | Approved | None posted |
| Dec 22, 2025 | Supplement 38Labeling · Standard review | Approved | None posted |
| Dec 22, 2025 | Supplement 40Labeling · Standard review | Approved | None posted |
| Oct 31, 2024 | Supplement 39REMS | Approved | None posted |
| Dec 15, 2023 | Supplement 35Labeling · Standard review | Approved | None posted |
| Dec 15, 2023 | Supplement 37Labeling · Standard review | Approved | None posted |
| Dec 8, 2023 | Supplement 29Labeling · Standard review | Approved | None posted |
| May 6, 2020 | Supplement 19Labeling · Standard review | Approved | None posted |
| May 6, 2020 | Supplement 21Labeling · Standard review | Approved | None posted |
| May 6, 2020 | Supplement 23Labeling · Standard review | Approved | None posted |
| May 6, 2020 | Supplement 24Labeling · Standard review | Approved | None posted |
| May 6, 2020 | Supplement 25Labeling · Standard review | Approved | None posted |
| Sep 18, 2018 | Supplement 20REMS | Approved | None posted |
| May 26, 2017 | Supplement 17REMS | Approved | None posted |
| Sep 30, 2016 | Supplement 16REMS | Approved | None posted |
| Apr 20, 2016 | Supplement 12REMS | Approved | None posted |
| Jun 26, 2015 | Supplement 11REMS | Approved | None posted |
| Jun 11, 2015 | Supplement 2Manufacturing | Approved | None posted |
| Aug 19, 2014 | Supplement 10REMS | Approved | None posted |
| Jun 16, 2014 | Supplement 8Labeling · Standard review | Approved | None posted |
| Apr 15, 2013 | Supplement 6REMS | Approved | None posted |
| Jul 9, 2012 | Supplement 3REMS | Approved | None posted |
| Jul 9, 2012 | Supplement 5Labeling | Approved | None posted |
| Feb 9, 2011 | 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