🇺🇸 Carbidopa Levodopa in United States

FDA authorised Carbidopa Levodopa on 11 June 2003

Marketing authorisations

FDA — authorised 11 June 2003

  • Application: NDA021485
  • Marketing authorisation holder: ORION PHARMA
  • Status: supplemented

FDA — authorised 25 January 2022

  • Application: ANDA213212
  • Marketing authorisation holder: RISING
  • Status: approved

FDA — authorised 21 September 2022

  • Application: ANDA216505
  • Marketing authorisation holder: RUBICON RESEARCH
  • Status: approved

FDA — authorised 15 April 2025

  • Application: ANDA214495
  • Marketing authorisation holder: MACLEODS PHARMS LTD
  • Status: approved

FDA — authorised 5 February 2026

  • Application: ANDA218535
  • Marketing authorisation holder: ALEMBIC
  • Status: approved

FDA

  • Status: approved

Carbidopa Levodopa 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 Carbidopa Levodopa approved in United States?

Yes. FDA authorised it on 11 June 2003; FDA authorised it on 25 January 2022; FDA authorised it on 21 September 2022.

Who is the marketing authorisation holder for Carbidopa Levodopa in United States?

ORION PHARMA holds the US marketing authorisation.