FDA — authorised 16 July 2008
- Application: ANDA078713
- Marketing authorisation holder: HIKMA
- Local brand name: INDOMETHACIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 INDOMETHACIN SODIUM in United States
FDA authorised INDOMETHACIN SODIUM on 16 July 2008
Marketing authorisations
FDA — authorised 19 April 2016
- Application: ANDA204118
- Marketing authorisation holder: HOSPIRA
- Local brand name: INDOMETHACIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 July 2017
- Application: ANDA206561
- Marketing authorisation holder: NAVINTA LLC
- Local brand name: INDOMETHACIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
INDOMETHACIN SODIUM in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is INDOMETHACIN SODIUM approved in United States?
Yes. FDA authorised it on 16 July 2008; FDA authorised it on 19 April 2016; FDA authorised it on 19 July 2017.
Who is the marketing authorisation holder for INDOMETHACIN SODIUM in United States?
HIKMA holds the US marketing authorisation.