For vasodilatory shock. ANDA 213206, held by Fresenius Kabi USA. Vasopressin.
As of Nov 15, 2026, ANDA 213206 (Vasopressin), held by Fresenius Kabi USA, was first approved by FDA on May 26, 2023, with 0 approved supplements and 0 published complete response letters.
Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 26, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vasopressin20UNITS/ML (20UNITS/ML) · solution;intravenous | Vasopressin | Rx |
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
