FDA — authorised 5 May 2008
- Application: ANDA078110
- Marketing authorisation holder: PRINSTON INC
- Local brand name: ROPINIROLE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 ROPINIROLE HYDROCHLORIDE in United States
FDA authorised ROPINIROLE HYDROCHLORIDE on 5 May 2008
Marketing authorisations
FDA — authorised 5 May 2008
- Application: ANDA077460
- Marketing authorisation holder: COSETTE
- Local brand name: ROPINIROLE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 May 2008
- Application: ANDA077852
- Marketing authorisation holder: HIKMA
- Local brand name: ROPINIROLE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 May 2008
- Application: ANDA078881
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ROPINIROLE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 May 2008
- Application: ANDA078230
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: ROPINIROLE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 May 2008
- Application: ANDA079050
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ROPINIROLE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 February 2010
- Application: ANDA090135
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: ROPINIROLE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 March 2010
- Application: ANDA090429
- Marketing authorisation holder: ALEMBIC LTD
- Local brand name: ROPINIROLE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 February 2012
- Application: ANDA079165
- Marketing authorisation holder: MLV
- Local brand name: ROPINIROLE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 May 2012
- Application: ANDA090869
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: ROPINIROLE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 6 June 2012
- Application: ANDA201047
- Marketing authorisation holder: SANDOZ INC
- Local brand name: ROPINIROLE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 6 June 2012
- Application: ANDA200431
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: ROPINIROLE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 6 June 2012
- Application: ANDA201576
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: ROPINIROLE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 15 October 2012
- Application: ANDA200462
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: ROPINIROLE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 November 2012
- Application: ANDA079229
- Marketing authorisation holder: ORBION PHARMS
- Local brand name: ROPINIROLE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 February 2017
- Application: ANDA204022
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: ROPINIROLE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 May 2022
- Application: ANDA204413
- Marketing authorisation holder: PRINSTON INC
- Local brand name: ROPINIROLE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 November 2025
- Application: ANDA217862
- Marketing authorisation holder: ELITE LABS INC
- Local brand name: ROPINIROLE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Status: approved
ROPINIROLE HYDROCHLORIDE 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 ROPINIROLE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 5 May 2008; FDA authorised it on 5 May 2008; FDA authorised it on 5 May 2008.
Who is the marketing authorisation holder for ROPINIROLE HYDROCHLORIDE in United States?
PRINSTON INC holds the US marketing authorisation.