Treats supraventricular tachycardia, including Wolff‑Parkinson‑White syndrome and…. ANDA 77760, held by Hikma Farmaceutica. Propranolol Hydrochloride.
As of Nov 15, 2026, ANDA 77760 (Propranolol Hydrochloride), held by Hikma Farmaceutica, was first approved by FDA on Jan 31, 2008, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Cardiac Arrhythmias Intravenous administration is usually reserved for life-threatening arrhythmias or those occurring under anesthesia. 1. Supraventricular arrhythmias Intravenous propranolol is indicated for the short-term treatment of supraventricular tachycardia, including Wolff‑Parkinson‑White syndrome and thyrotoxicosis, to decrease ventricular rate. Use in patients with atrial flutter or atrial fibrillation should be reserved for arrythmias unresponsive to standard therapy or when more prolonged control is required. Reversion to normal sinus rhythm has occasionally been observed, predominantly in patients with sinus or atrial tachycardia. 2.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 31, 2008 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Propranolol Hydrochloride1MG/ML · injectable;injection | Propranolol Hydrochloride | Rx |
| Jul 1, 2015 | Supplement 8Labeling | Approved | None posted |
| Jan 31, 2008 | Original application | Approved | None posted |
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
