🇺🇸 Acetadote in United States

FDA authorised Acetadote on 23 January 2004

Marketing authorisations

FDA — authorised 23 January 2004

  • Application: NDA021539
  • Marketing authorisation holder: CUMBERLAND PHARMS
  • Status: supplemented

FDA

  • Status: approved

Acetadote in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Respiratory approved in United States

Frequently asked questions

Is Acetadote approved in United States?

Yes. FDA authorised it on 23 January 2004; FDA has authorised it.

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

CUMBERLAND PHARMS holds the US marketing authorisation.