FDA — authorised 13 July 1950
- Marketing authorisation holder: HOSPIRA
- Status: approved
🇺🇸 Norepinephrine Bitartrate In 5% Dextrose in United States
FDA authorised Norepinephrine Bitartrate In 5% Dextrose on 13 July 1950
Marketing authorisations
FDA — authorised 31 August 2015
- Application: ANDA040455
- Marketing authorisation holder: MEITHEAL
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 4 October 2018
- Application: ANDA211242
- Marketing authorisation holder: MYLAN LABS LTD
- Status: approved
FDA — authorised 17 December 2018
- Application: ANDA210839
- Marketing authorisation holder: AMNEAL
- Status: approved
FDA — authorised 15 January 2021
- Application: NDA214313
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 6 October 2022
- Application: NDA214628
- Marketing authorisation holder: LONG GROVE PHARMS
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 15 September 2023
- Application: ANDA217575
- Marketing authorisation holder: CAPLIN
- Status: approved
FDA — authorised 11 August 2025
- Application: ANDA219692
- Marketing authorisation holder: SAGENT
- Local brand name: NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 26 March 2026
- Application: ANDA220483
- Marketing authorisation holder: SAGENT
- Local brand name: NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
Norepinephrine Bitartrate In 5% Dextrose 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 Norepinephrine Bitartrate In 5% Dextrose approved in United States?
Yes. FDA authorised it on 13 July 1950; FDA authorised it on 31 August 2015; FDA authorised it on 4 October 2018.
Who is the marketing authorisation holder for Norepinephrine Bitartrate In 5% Dextrose in United States?
HOSPIRA holds the US marketing authorisation.