FDA — authorised 14 January 2011
- Marketing authorisation holder: HOPE PHARMS
- Status: approved
🇺🇸 Sodium Nitrite in United States
FDA authorised Sodium Nitrite on 14 January 2011
Marketing authorisations
FDA — authorised 8 April 2013
- Application: NDA201444
- Marketing authorisation holder: HOPE PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 19 October 2017
- Application: NDA203922
- Marketing authorisation holder: HOPE PHARMS
- Indication: Labeling
- Status: approved
Sodium Nitrite in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Sodium Nitrite approved in United States?
Yes. FDA authorised it on 14 January 2011; FDA authorised it on 8 April 2013; FDA authorised it on 19 October 2017.
Who is the marketing authorisation holder for Sodium Nitrite in United States?
HOPE PHARMS holds the US marketing authorisation.