NDA 21338, held by The Medicines Co. Fentanyl Hydrochloride.
As of Nov 14, 2026, NDA 21338 (Ionsys), held by The Medicines Co, was first approved by FDA on May 22, 2006, with 5 approved supplements and 0 published complete response letters.
| Apr 30, 2015 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| May 22, 2006 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| IonsysEQ 40MCG BASE/ACTIVATION · system;iontophoresis, transdermal | Fentanyl Hydrochloride | DiscontinuedReference drug |
| Oct 3, 2018 | Supplement 10REMS | Approved | None posted |
| Mar 29, 2017 | Supplement 9REMS | Approved | |
| Dec 16, 2016 | Supplement 7Labeling · Standard review | Approved | |
| Nov 12, 2015 | Supplement 6REMS | Approved | |
| Apr 30, 2015 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| May 22, 2006 | Original applicationNew dosage form · Standard review | 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
