FDA — authorised 30 October 2014
- Application: ANDA203783
- Marketing authorisation holder: BRIGHAM WOMENS HOSP
- Status: approved
🇺🇸 ammonia in United States
FDA authorised ammonia on 30 October 2014
Marketing authorisations
FDA — authorised 2 November 2015
- Application: ANDA204510
- Marketing authorisation holder: PETNET
- Status: approved
FDA — authorised 21 December 2018
- Application: ANDA210524
- Marketing authorisation holder: IONETIX
- Status: approved
FDA — authorised 1 November 2019
- Application: ANDA209507
- Marketing authorisation holder: UNIV TX SW MEDCTR
- Status: approved
FDA — authorised 24 June 2020
- Application: ANDA203779
- Marketing authorisation holder: 3D IMAGING DRUG
- Indication: Manufacturing (CMC)
- Status: approved
ammonia in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is ammonia approved in United States?
Yes. FDA authorised it on 30 October 2014; FDA authorised it on 2 November 2015; FDA authorised it on 21 December 2018.
Who is the marketing authorisation holder for ammonia in United States?
BRIGHAM WOMENS HOSP holds the US marketing authorisation.