For hypotension associated with septic shock. NDA 211363, held by Intl Medication Sys. Epinephrine.
As of Nov 14, 2026, NDA 211363 (Epinephrine), held by Intl Medication Sys, was first approved by FDA on Aug 15, 2022, with 0 approved supplements and 1 published complete response letter.
Epinephrine is a non-selective alpha and beta adrenergic agonist indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. 1.1 Hypotension associated with Septic Shock
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 15, 2022 | Original applicationTYPE 7 · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Dec 12, 2018 | NDA 211363Product Quality | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Epinephrine1MG/10ML (0.1MG/ML) · solution;intravenous | Epinephrine | 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
