🇺🇸 Kristalose in United States

FDA authorised Kristalose on 10 December 1997

Marketing authorisations

FDA — authorised 10 December 1997

  • Application: ANDA074712
  • Marketing authorisation holder: CUMBERLAND PHARMS
  • Status: supplemented

FDA

  • Status: approved

Other Other approved in United States

Frequently asked questions

Is Kristalose approved in United States?

Yes. FDA authorised it on 10 December 1997; FDA has authorised it.

Who is the marketing authorisation holder for Kristalose in United States?

CUMBERLAND PHARMS holds the US marketing authorisation.