🇺🇸 Sivelestat sodium hydrate in United States

Sivelestat sodium hydrate (Sivelestat sodium hydrate) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Sivelestat sodium hydrate 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 Sivelestat sodium hydrate approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Sivelestat sodium hydrate in United States?

Ono Pharmaceutical Co. Ltd is the originator. The local marketing authorisation holder may differ — check the official source linked above.