FDA — authorised 14 February 1992
- Marketing authorisation holder: US ARMY
- Status: approved
🇺🇸 Sodium Thiosulfate in United States
FDA authorised Sodium Thiosulfate on 14 February 1992
Marketing authorisations
FDA — authorised 14 February 1992
- Application: NDA020166
- Marketing authorisation holder: US ARMY
- Local brand name: SODIUM THIOSULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 February 2012
- Application: NDA203923
- Marketing authorisation holder: HOPE PHARMS
- Local brand name: SODIUM THIOSULFATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 8 April 2013
- Application: NDA201444
- Marketing authorisation holder: HOPE PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 20 September 2022
- Application: NDA212937
- Marketing authorisation holder: FENNEC PHARMS INC
- Local brand name: PEDMARK
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
Sodium Thiosulfate 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 Thiosulfate approved in United States?
Yes. FDA authorised it on 14 February 1992; FDA authorised it on 14 February 1992; FDA authorised it on 14 February 2012.
Who is the marketing authorisation holder for Sodium Thiosulfate in United States?
US ARMY holds the US marketing authorisation.