For vasodilatory shock. ANDA 216963, held by Gland. Vasopressin.
As of Nov 15, 2026, ANDA 216963 (Vasopressin, Vasopressin In Dextrose 5%), held by Gland, was first approved by FDA on Feb 9, 2024, 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 |
|---|---|---|---|
| Feb 9, 2024 | Original application | Approved | None posted |
| Vasopressin20UNITS/ML (20UNITS/ML) · solution;intravenous | Vasopressin | Rx |
| Vasopressin In Dextrose 5%40UNITS/100ML (0.4UNITS/ML) · solution;intravenous | Vasopressin | Rx |
| Vasopressin In Dextrose 5%20UNITS/100ML (0.2UNITS/ML) · solution;intravenous | Vasopressin | None (tentative approval) |
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
