For vasodilatory shock. NDA 217569, held by Baxter Hlthcare Corp. Vasopressin.
As of Nov 13, 2026, NDA 217569 (Vasopressin In Sodium Chloride 0.9%), held by Baxter Hlthcare Corp, was first approved by FDA on Sep 29, 2023, with 2 approved supplements and 0 published complete response letters.
Vasopressin in Sodium Chloride Injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 29, 2023 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vasopressin In Sodium Chloride 0.9%20UNITS/100ML (0.2UNITS/ML) · solution;intravenous | Vasopressin | RxReference drug |
| Vasopressin In Sodium Chloride 0.9%40UNITS/100ML (0.4UNITS/ML) · solution;intravenous | Vasopressin | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 21, 2025 | Supplement 3Labeling · Standard review | Approved | |
| Feb 5, 2024 | Supplement 1Manufacturing | Approved | |
| Sep 29, 2023 | Original applicationNew formulation or manufacturer · Standard review | 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
