NDA 201811, held by Fresenius Kabi USA. Argatroban.
As of Nov 14, 2026, NDA 201811 (Argatroban), held by Fresenius Kabi USA, was first approved by FDA on Mar 23, 2015, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 23, 2015 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Argatroban250MG/2.5ML (100MG/ML) · injectable;injection | Argatroban | Discontinued |
| Jul 13, 2026 | Supplement 12Labeling · Standard review | Approved | |
| Jan 30, 2018 | Supplement 6Labeling · Standard review | Approved | |
| May 25, 2016 | Supplement 3Labeling · Standard review | Approved | |
| Dec 11, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 23, 2015 | 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
