FDA — authorised 31 October 2011
- Application: ANDA090429
- Marketing authorisation holder: ALEMBIC LTD
- Indication: Labeling
- Status: approved
🇺🇸 Requip in United States
FDA authorised Requip on 31 October 2011
Marketing authorisations
FDA — authorised 11 December 2015
- Application: ANDA078110
- Marketing authorisation holder: PRINSTON INC
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 10 January 2016
- Application: ANDA202786
- Marketing authorisation holder: ALEMBIC
- Indication: Labeling
- Status: approved
FDA — authorised 27 October 2022
- Application: ANDA090135
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 28 October 2022
- Application: ANDA079165
- Marketing authorisation holder: MLV
- Indication: Labeling
- Status: approved
Requip in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Requip approved in United States?
Yes. FDA authorised it on 31 October 2011; FDA authorised it on 11 December 2015; FDA authorised it on 10 January 2016.
Who is the marketing authorisation holder for Requip in United States?
ALEMBIC LTD holds the US marketing authorisation.