ANDA 220562, held by Hikma. Epinephrine.
As of Nov 14, 2026, ANDA 220562 (Epinephrine), held by Hikma, was first approved by FDA on May 29, 2026, with 0 approved supplements and 0 published complete response letters.
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 For emergency treatment of allergic reactions (Type 1), including anaphylaxis 1.1 Hypotension associated with Septic Shock Epinephrine Injection 1 mg/mL is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 29, 2026 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Epinephrine1MG/ML (1MG/ML) · solution;intramuscular, intravenous, subcutaneous | Epinephrine | 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
