Esmolol Hydrochloride In Plastic Container, Esmolol Hydrochloride Double Strength In Plastic Container

Controls ventricular rate in supraventricular tachycardia including atrial fibrillation…. NDA 205703, held by Hq Spclt Pharma. Esmolol Hydrochloride.

As of Nov 15, 2026, NDA 205703 (Esmolol Hydrochloride In Plastic Container, Esmolol Hydrochloride Double Strength In Plastic Container), held by Hq Spclt Pharma, was first approved by FDA on Apr 7, 2016, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 7, 2016
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Esmolol Hydrochloride is a beta-adrenergic blocker indicated for the short-term treatment of:

Control of ventricular rate in supraventricular tachycardia including atrial fibrillation and atrial flutter and control of heart rate in noncompensatory sinus tachycardia
Control of perioperative tachycardia and hypertension 1.1 Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia Esmolol hydrochloride is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short-term control of ventricular rate is desirable.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Apr 7, 2016	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Label

Products

2 strengths and forms


Esmolol Hydrochloride In Plastic Container2.5GM/250ML (10MG/ML) · solution;intravenous	Esmolol Hydrochloride	RxReference drug
Esmolol Hydrochloride Double Strength In Plastic Container2GM/100ML (20MG/ML) · solution;intravenous	Esmolol Hydrochloride	RxReference drug

All 2 submissions, including labeling and manufacturing supplements


May 2, 2024	Supplement 3Labeling · Standard review	Approved	Label Letter
Apr 7, 2016	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 205703
Drugs@FDA: Overview at FDA
Company: HQ Specialty Pharma

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