FDA — authorised 31 December 1986
- Application: NDA019386
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 ESMOLOL HYDROCHLORIDE in United States
FDA authorised ESMOLOL HYDROCHLORIDE on 31 December 1986 · 109 US adverse-event reports
Marketing authorisations
FDA — authorised 10 August 2004
- Application: ANDA076323
- Marketing authorisation holder: HIKMA
- Local brand name: ESMOLOL HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 May 2005
- Application: ANDA076573
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: ESMOLOL HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 May 2005
- Application: ANDA076474
- Marketing authorisation holder: MYLAN INSTITUTIONAL
- Local brand name: ESMOLOL HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 February 2015
- Application: ANDA201126
- Marketing authorisation holder: AM REGENT
- Local brand name: ESMOLOL HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 July 2015
- Application: ANDA205520
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: ESMOLOL HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 April 2016
- Application: NDA205703
- Marketing authorisation holder: HQ SPCLT PHARMA
- Local brand name: ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 8 June 2018
- Application: ANDA207107
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: ESMOLOL HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 June 2018
- Application: ANDA206608
- Marketing authorisation holder: MYLAN LABS LTD
- Status: approved
FDA — authorised 14 August 2019
- Application: ANDA208538
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 21 March 2022
- Application: ANDA216244
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: ESMOLOL HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 December 2022
- Application: ANDA214172
- Marketing authorisation holder: HQ SPCLT PHARMA
- Local brand name: ESMOLOL HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 December 2022
- Application: ANDA216603
- Marketing authorisation holder: AMNEAL
- Local brand name: ESMOLOL HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 109
Most-reported reactions
- Drug Ineffective — 25 reports (22.94%)
- Product Use In Unapproved Indication — 17 reports (15.6%)
- Product Use Issue — 17 reports (15.6%)
- Hypotension — 9 reports (8.26%)
- Cardiac Arrest — 8 reports (7.34%)
- Condition Aggravated — 8 reports (7.34%)
- Overdose — 7 reports (6.42%)
- Cardiogenic Shock — 6 reports (5.5%)
- Drug Ineffective For Unapproved Indication — 6 reports (5.5%)
- Hepatotoxicity — 6 reports (5.5%)
ESMOLOL HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is ESMOLOL HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 31 December 1986; FDA authorised it on 10 August 2004; FDA authorised it on 2 May 2005.
Who is the marketing authorisation holder for ESMOLOL HYDROCHLORIDE in United States?
BAXTER HLTHCARE holds the US marketing authorisation.