For vasodilatory shock. NDA 212593, held by Am Regent. Vasopressin.
As of Nov 14, 2026, NDA 212593 (Vasopressin), held by Am Regent, was first approved by FDA on Aug 3, 2020, 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 |
|---|---|---|---|
| Aug 3, 2020 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Vasopressin20UNITS/ML (20UNITS/ML) · solution;intravenous | Vasopressin | RxReference drug |
| Vasopressin200UNITS/10ML (20UNITS/ML) · solution;intravenous | Vasopressin | RxReference drug |
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
