🇺🇸 PRAMIPEXOLE in United States

FDA authorised PRAMIPEXOLE on 28 October 2014

Marketing authorisations

FDA — authorised 28 October 2014

  • Application: ANDA203855
  • Marketing authorisation holder: SCIEGEN PHARMS
  • Status: supplemented

FDA — authorised 24 June 2016

  • Application: ANDA206156
  • Marketing authorisation holder: MACLEODS PHARMS LTD
  • Status: supplemented

FDA — authorised 19 December 2018

  • Application: ANDA207011
  • Marketing authorisation holder: UNICHEM
  • Status: supplemented

FDA — authorised 2 January 2019

  • Application: ANDA204518
  • Marketing authorisation holder: ALEMBIC
  • Status: supplemented

FDA — authorised 3 February 2022

  • Application: ANDA213444
  • Marketing authorisation holder: NOVAST LABS
  • Status: approved

FDA

  • Status: approved

PRAMIPEXOLE 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 PRAMIPEXOLE approved in United States?

Yes. FDA authorised it on 28 October 2014; FDA authorised it on 24 June 2016; FDA authorised it on 19 December 2018.

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

SCIEGEN PHARMS holds the US marketing authorisation.