Treats proliferating infantile hemangioma requiring systemic therapy. NDA 205410, held by Eton. Propranolol Hydrochloride.
As of Nov 14, 2026, NDA 205410 (Hemangeol), held by Eton, was first approved by FDA on Mar 14, 2014, with 5 approved supplements and 0 published complete response letters.
HEMANGEOL oral solution contains the beta-adrenergic blocker propranolol hydrochloride and is indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 14, 2014 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hemangeol4.28MG/ML · solution;oral | Propranolol Hydrochloride | RxReference drug |
| Aug 28, 2026 | Supplement 7Labeling · Standard review | Approved | |
| Jun 22, 2021 | Supplement 6Labeling · Standard review | Approved | |
| Apr 2, 2020 | Supplement 5Labeling · Standard review | Approved | |
| Dec 18, 2019 | Supplement 3Labeling · Standard review | Approved | |
| May 18, 2015 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Mar 14, 2014 | Original applicationNew formulation or manufacturer · 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
