NDA 22536, held by Fresenius Kabi USA. Indomethacin.
As of Nov 14, 2026, NDA 22536 (Indomethacin), held by Fresenius Kabi USA, was first approved by FDA on Mar 17, 2010, with 2 approved supplements and 0 published complete response letters.
Indomethacin for Injection is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1,750 g when 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective. Clear-cut clinical evidence of a hemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly, or pulmonary plethora on chest x-ray.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 17, 2010 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| IndomethacinEQ 1MG BASE/VIAL · injectable;injection | Indomethacin | RxReference drug |
| Dec 21, 2021 | Supplement 8Labeling · Standard review | Approved | |
| Jun 5, 2015 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Mar 17, 2010 | Original applicationNew formulation or manufacturer · 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
