🇺🇸 Humulin R U-500 in United States

FDA authorised Humulin R U-500 on 28 October 1982

Marketing authorisations

FDA — authorised 28 October 1982

  • Application: BLA018780
  • Marketing authorisation holder: LILLY
  • Status: supplemented

FDA

  • Status: approved

Humulin R U-500 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 Humulin R U-500 approved in United States?

Yes. FDA authorised it on 28 October 1982; FDA has authorised it.

Who is the marketing authorisation holder for Humulin R U-500 in United States?

LILLY holds the US marketing authorisation.