For vasodilatory shock. ANDA 211857, held by Amphastar Pharms Inc. Vasopressin.
As of Nov 15, 2026, ANDA 211857 (Vasopressin), held by Amphastar Pharms Inc, was first approved by FDA on Jul 18, 2022, with 0 approved supplements and 0 published complete response letters.
Vasopressin Injection, USP is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 18, 2022 | Original application | Approved |
| 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