Treats allergic reactions (Type 1), including anaphylaxis. ANDA 218208, held by Amneal. Epinephrine.
As of Nov 14, 2026, ANDA 218208 (Epinephrine), held by Amneal, was first approved by FDA on Dec 8, 2025, with 0 approved supplements and 0 published complete response letters.
Epinephrine is a non-selective alpha and beta adrenergic agonist indicated for: Emergency treatment of allergic reactions (Type 1), including anaphylaxis. To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. 1.1 Anaphylaxis Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 8, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| EpinephrineEQ 1MG BASE/ML (EQ 1MG BASE/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
