ANDA 219239, held by Gland. Epinephrine.
As of Nov 14, 2026, ANDA 219239 (Epinephrine), held by Gland, was first approved by FDA on Feb 6, 2025, with 1 approved supplement 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 |
|---|---|---|---|
| Feb 6, 2025 | Original application | Approved |
| Epinephrine10MG/10ML (1MG/ML) · solution;intramuscular, intravenous, subcutaneous | Epinephrine | Rx |
| Epinephrine30MG/30ML (1MG/ML) · solution;intramuscular, intravenous, subcutaneous | Epinephrine | Rx |
| Epinephrine1MG/ML (1MG/ML) · solution;intramuscular, intravenous, subcutaneous | Epinephrine | Rx |
| Sep 22, 2026 | Supplement 2Manufacturing | Approved | None posted |
| Feb 6, 2025 | Original application | 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
