ANDA 204120, held by Hospira. Argatroban.
As of Nov 15, 2026, ANDA 204120 (Argatroban), held by Hospira, was first approved by FDA on Sep 21, 2016, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 21, 2016 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Argatroban250MG/2.5ML (100MG/ML) · injectable;injection | Argatroban | Discontinued |
| Aug 27, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 21, 2016 | Original application | 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
