FDA — authorised 23 December 1987
- Status: approved
🇺🇸 Ammonul in United States
FDA authorised Ammonul on 23 December 1987
Marketing authorisations
FDA — authorised 23 December 1987
- Application: NDA019530
- Marketing authorisation holder: B BRAUN
- Local brand name: UCEPHAN
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 24 February 2016
- Application: ANDA207096
- Marketing authorisation holder: AILEX PHARMS LLC
- Local brand name: SODIUM PHENYLACETATE AND SODIUM BENZOATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 4 August 2016
- Application: ANDA205880
- Marketing authorisation holder: NAVINTA LLC
- Local brand name: SODIUM PHENYLACETATE AND SODIUM BENZOATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 10 June 2021
- Application: NDA215025
- Marketing authorisation holder: MAIA PHARMS INC
- Local brand name: SODIUM PHENYLACETATE AND SODIUM BENZOATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 14 July 2023
- Application: ANDA217526
- Marketing authorisation holder: NAVINTA LLC
- Local brand name: SODIUM PHENYLACETATE AND SODIUM BENZOATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
Ammonul in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Ammonul approved in United States?
Yes. FDA authorised it on 23 December 1987; FDA authorised it on 23 December 1987; FDA authorised it on 24 February 2016.
Who is the marketing authorisation holder for Ammonul in United States?
Marketing authorisation holder not available in our data.