Treats allergic reactions (Type 1), including anaphylaxis. ANDA 217192, held by Am Regent. Epinephrine.
As of Nov 14, 2026, ANDA 217192 (Epinephrine), held by Am Regent, was first approved by FDA on Sep 6, 2024, with 0 approved supplements and 0 published complete response letters.
Epinephrine injection 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 |
|---|---|---|---|
| Sep 6, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| EpinephrineEQ 30MG BASE/30ML (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
