FDA — authorised 28 September 2013
- Application: NDA021038
- Marketing authorisation holder: HOSPIRA
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Dexmedetomidine Hydrochloride in United States
FDA authorised Dexmedetomidine Hydrochloride on 28 September 2013
Marketing authorisations
FDA — authorised 18 August 2014
- Application: ANDA202881
- Marketing authorisation holder: MYLAN INSTITUTIONAL
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 August 2014
- Application: ANDA203972
- Marketing authorisation holder: PH HEALTH
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 November 2014
- Application: ANDA202585
- Marketing authorisation holder: RISING
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 August 2015
- Application: ANDA202126
- Marketing authorisation holder: GLAND
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 September 2015
- Application: ANDA201072
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 February 2016
- Application: ANDA204023
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 March 2016
- Application: ANDA205867
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 June 2016
- Application: ANDA091465
- Marketing authorisation holder: CAPLIN
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 October 2016
- Application: ANDA204686
- Marketing authorisation holder: ACTAVIS INC
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 April 2017
- Application: ANDA205046
- Marketing authorisation holder: HIKMA
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 May 2017
- Application: ANDA203773
- Marketing authorisation holder: AM REGENT
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 September 2017
- Application: ANDA209065
- Marketing authorisation holder: HENGRUI PHARMA
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 November 2017
- Application: ANDA205272
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 February 2018
- Application: ANDA206798
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 November 2018
- Application: ANDA208129
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA — authorised 18 January 2019
- Application: ANDA204843
- Marketing authorisation holder: MEITHEAL
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 December 2019
- Application: ANDA212791
- Marketing authorisation holder: WILSHIRE PHARMS INC
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 January 2020
- Application: ANDA206407
- Marketing authorisation holder: HIKMA
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 May 2020
- Application: ANDA207551
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 June 2020
- Application: ANDA209307
- Marketing authorisation holder: GLAND
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 August 2020
- Application: ANDA212571
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 September 2020
- Application: ANDA208266
- Marketing authorisation holder: PH HEALTH
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 November 2020
- Application: ANDA212857
- Marketing authorisation holder: TAGI
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 December 2020
- Application: ANDA210321
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 September 2021
- Application: ANDA214794
- Marketing authorisation holder: PIRAMAL CRITICAL
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 May 2023
- Application: ANDA216604
- Marketing authorisation holder: AMNEAL
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 June 2023
- Application: ANDA217308
- Marketing authorisation holder: MILLA PHARMS
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 September 2024
- Application: ANDA218112
- Marketing authorisation holder: SOMERSET
- Status: approved
FDA — authorised 25 February 2026
- Application: ANDA220315
- Marketing authorisation holder: DR REDDYS
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 March 2026
- Application: ANDA218675
- Marketing authorisation holder: KNACK
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 April 2026
- Application: ANDA208103
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: DEXMEDETOMIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
Pricing & reimbursement
- annual_list: USD 1.68 per year
Dexmedetomidine Hydrochloride in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Dexmedetomidine Hydrochloride approved in United States?
Yes. FDA authorised it on 28 September 2013; FDA authorised it on 18 August 2014; FDA authorised it on 18 August 2014.
Who is the marketing authorisation holder for Dexmedetomidine Hydrochloride in United States?
HOSPIRA holds the US marketing authorisation.
What does Dexmedetomidine Hydrochloride cost in United States?
annual_list: USD 1.68 per year. Final patient cost depends on reimbursement and any patient access scheme.