FDA — authorised 13 August 1946
- Marketing authorisation holder: ELKINS SINN
- Status: approved
🇺🇸 Sotradecol in United States
FDA authorised Sotradecol on 13 August 1946
Marketing authorisations
FDA — authorised 13 August 1946
- Application: NDA005970
- Marketing authorisation holder: ELKINS SINN
- Local brand name: SOTRADECOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 November 2004
- Application: ANDA040541
- Marketing authorisation holder: MYLAN INSTITUTIONAL
- Local brand name: SOTRADECOL
- Indication: INJECTABLE — INJECTION
- Status: approved
Sotradecol 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 Sotradecol approved in United States?
Yes. FDA authorised it on 13 August 1946; FDA authorised it on 13 August 1946; FDA authorised it on 12 November 2004.
Who is the marketing authorisation holder for Sotradecol in United States?
ELKINS SINN holds the US marketing authorisation.