FDA — authorised 31 March 2005
- Application: NDA021689
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: NEXIUM IV
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
🇺🇸 Esomeprazole (Intravenous) in United States
FDA authorised Esomeprazole (Intravenous) on 31 March 2005
Marketing authorisations
FDA — authorised 18 March 2013
- Application: ANDA200882
- Marketing authorisation holder: SUN PHARM
- Local brand name: ESOMEPRAZOLE SODIUM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 6 March 2017
- Application: ANDA207181
- Marketing authorisation holder: DEVA HOLDING AS
- Local brand name: ESOMEPRAZOLE SODIUM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 1 April 2020
- Application: ANDA203349
- Marketing authorisation holder: GLAND
- Local brand name: ESOMEPRAZOLE SODIUM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 10 February 2022
- Application: ANDA215732
- Marketing authorisation holder: SLATE RUN PHARMA
- Local brand name: ESOMEPRAZOLE SODIUM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 8 January 2025
- Application: ANDA214046
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: ESOMEPRAZOLE SODIUM
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
Other Gastroenterology approved in United States
Frequently asked questions
Is Esomeprazole (Intravenous) approved in United States?
Yes. FDA authorised it on 31 March 2005; FDA authorised it on 18 March 2013; FDA authorised it on 6 March 2017.
Who is the marketing authorisation holder for Esomeprazole (Intravenous) in United States?
ASTRAZENECA holds the US marketing authorisation.