NDA 22504, held by Eli Lilly And Co. Testosterone.
As of Nov 13, 2026, NDA 22504 (Axiron), held by Eli Lilly And Co, was first approved by FDA on Nov 23, 2010, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 23, 2010 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Axiron30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution, metered;transdermal | Testosterone | DiscontinuedReference drug |
| Jul 13, 2017 | Supplement 16Labeling · Standard review | Approved | |
| Feb 3, 2017 | Supplement 13Labeling · Standard review | Approved | |
| Jan 23, 2017 | Supplement 15REMS | Approved | |
| Oct 25, 2016 | Supplement 14Labeling · Standard review | Approved | |
| May 11, 2015 | Supplement 12Labeling · Standard review | Approved | |
| Jun 19, 2014 | Supplement 11Labeling · Standard review | Approved | |
| Feb 27, 2014 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jan 15, 2014 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| May 29, 2013 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Dec 22, 2011 | Supplement 5Labeling · Standard review | Approved | |
| Mar 31, 2011 | Supplement 2REMS | Approved | |
| Nov 23, 2010 | 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
