Treats allergic reactions (Type 1), including anaphylaxis. NDA 204640, held by Ph Health. Epinephrine.
As of Nov 13, 2026, NDA 204640 (Adrenalin), held by Ph Health, was first approved by FDA on Dec 18, 2013, with 7 approved supplements and 0 published complete response letters.
Adrenalin 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.
| Jan 29, 2019 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Dec 18, 2013 | Original applicationTYPE 7 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| AdrenalinEQ 30MG BASE/30ML (EQ 1MG BASE/ML) · solution;intramuscular, intravenous, subcutaneous | Epinephrine | RxReference drug |
| Jun 22, 2026 | Supplement 22Labeling · Standard review | Approved | |
| Jan 5, 2023 | Supplement 18Labeling · Standard review | Approved | |
| Aug 17, 2021 | Supplement 12Manufacturing | Approved | |
| Jan 29, 2019 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Aug 9, 2017 | Supplement 8Labeling · Standard review | Approved | |
| May 18, 2016 | Supplement 3Labeling | Approved | |
| Dec 23, 2015 | Supplement 2Manufacturing · Standard review | Approved | |
| Dec 18, 2013 | Original applicationTYPE 7 · Standard review | Approved |
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
