FDA — authorised 10 May 1974
- Marketing authorisation holder: ROCHE
- Status: approved
🇺🇸 Sodium Nitroprusside in United States
FDA authorised Sodium Nitroprusside on 10 May 1974
Marketing authorisations
FDA — authorised 30 March 1992
- Application: ANDA073465
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 December 2016
- Application: ANDA207426
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 March 2017
- Application: NDA209387
- Marketing authorisation holder: EXELA PHARMA
- Local brand name: NIPRIDE RTU IN SODIUM CHLORIDE 0.9%
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 4 May 2017
- Application: ANDA208635
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 May 2017
- Application: ANDA207499
- Marketing authorisation holder: NEXUS
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 December 2017
- Application: ANDA209352
- Marketing authorisation holder: MICRO LABS
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 April 2018
- Application: ANDA210763
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 November 2018
- Application: ANDA210467
- Marketing authorisation holder: SUN PHARM
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 April 2019
- Application: ANDA210114
- Marketing authorisation holder: DR REDDYS
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 November 2019
- Application: ANDA211016
- Marketing authorisation holder: CAPLIN
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 November 2022
- Application: ANDA208923
- Marketing authorisation holder: AVET LIFESCIENCES
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070031
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: SODIUM NITROPRUSSIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
Sodium Nitroprusside in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Sodium Nitroprusside approved in United States?
Yes. FDA authorised it on 10 May 1974; FDA authorised it on 30 March 1992; FDA authorised it on 8 December 2016.
Who is the marketing authorisation holder for Sodium Nitroprusside in United States?
ROCHE holds the US marketing authorisation.