FDA — authorised 3 September 1982
- Status: approved
🇺🇸 Visken in United States
FDA authorised Visken on 3 September 1982
Marketing authorisations
FDA — authorised 3 September 1982
- Application: NDA018285
- Marketing authorisation holder: NOVARTIS
- Local brand name: VISKEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 September 1992
- Application: ANDA074019
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: PINDOLOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 September 1992
- Application: ANDA074018
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: PINDOLOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 September 1992
- Application: ANDA074013
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: PINDOLOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 February 1993
- Application: ANDA073687
- Marketing authorisation holder: COSETTE
- Local brand name: PINDOLOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 March 1993
- Application: ANDA073609
- Marketing authorisation holder: ANI PHARMS
- Local brand name: PINDOLOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 1993
- Application: ANDA073661
- Marketing authorisation holder: COSETTE
- Local brand name: PINDOLOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 1994
- Application: ANDA074063
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: PINDOLOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 1995
- Application: ANDA074437
- Marketing authorisation holder: WATSON LABS
- Local brand name: PINDOLOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 August 2017
- Application: ANDA209866
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: PINDOLOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 August 2019
- Application: ANDA211712
- Marketing authorisation holder: UNICHEM
- Local brand name: PINDOLOL
- Indication: TABLET — ORAL
- Status: approved
Visken in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Visken approved in United States?
Yes. FDA authorised it on 3 September 1982; FDA authorised it on 3 September 1982; FDA authorised it on 3 September 1992.
Who is the marketing authorisation holder for Visken in United States?
Marketing authorisation holder not available in our data.