NDA 22028, held by Sandoz. Cosyntropin.
As of Nov 14, 2026, NDA 22028 (Cosyntropin), held by Sandoz, was first approved by FDA on Feb 21, 2008, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 21, 2008 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cosyntropin0.25MG/ML (0.25MG/ML) · solution;intravenous | Cosyntropin | Discontinued |
| Jul 1, 2024 | Supplement 7Labeling · Standard review | Approved | |
| Jul 16, 2021 | Supplement 6Labeling · Standard review | Approved | |
| May 11, 2018 | Supplement 5Labeling · Standard review | Approved | |
| Aug 7, 2013 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Feb 21, 2008 | 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
