FDA — authorised 23 December 1996
- Application: NDA020664
- Marketing authorisation holder: PFIZER
- Local brand name: DOSTINEX
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Dostinex in United States
FDA authorised Dostinex on 23 December 1996
Marketing authorisations
FDA — authorised 29 December 2005
- Application: ANDA076310
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: CABERGOLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 March 2007
- Application: ANDA077750
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: CABERGOLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 July 2007
- Application: ANDA077843
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: CABERGOLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 April 2008
- Application: ANDA078035
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: CABERGOLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 March 2013
- Application: ANDA201503
- Marketing authorisation holder: APOTEX CORP
- Local brand name: CABERGOLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 December 2013
- Application: ANDA202947
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CABERGOLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 August 2018
- Application: ANDA204735
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: CABERGOLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 June 2024
- Application: ANDA218618
- Marketing authorisation holder: AMNEAL
- Status: approved
FDA — authorised 9 September 2024
- Application: ANDA218109
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Status: approved
Dostinex 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 Dostinex approved in United States?
Yes. FDA authorised it on 23 December 1996; FDA authorised it on 29 December 2005; FDA authorised it on 7 March 2007.
Who is the marketing authorisation holder for Dostinex in United States?
PFIZER holds the US marketing authorisation.