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As of Nov 13, 2026, ANDA 202097 (Fentanyl-12, Fentanyl-25, Fentanyl-50), held by Kindeva, was first approved by FDA on Nov 4, 2016, with 10 approved supplements and 0 published complete response letters.
First approved: Nov 4, 2016
Supplements approved: 10
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
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.
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
