For vasodilatory shock. ANDA 212944, held by Amneal. Vasopressin.
As of Nov 15, 2026, ANDA 212944 (Vasopressin), held by Amneal, was first approved by FDA on Aug 5, 2022, with 1 approved supplement 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 5, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vasopressin20UNITS/ML (20UNITS/ML) · solution;intravenous | Vasopressin | Rx |
| Jul 21, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 5, 2022 | Original application | Approved | None posted |
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
