FDA — authorised 16 July 2012
- Application: ANDA090690
- Marketing authorisation holder: SUN PHARM
- Local brand name: ENTACAPONE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Comtan® in United States
FDA authorised Comtan® on 16 July 2012
Marketing authorisations
FDA — authorised 16 August 2012
- Application: ANDA078941
- Marketing authorisation holder: WOCKHARDT BIO AG
- Local brand name: ENTACAPONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 June 2015
- Application: ANDA203437
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ENTACAPONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 June 2017
- Application: ANDA207210
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: ENTACAPONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 August 2017
- Application: ANDA205792
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: ENTACAPONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 October 2018
- Application: ANDA206669
- Marketing authorisation holder: SUNSHINE
- Local brand name: ENTACAPONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 January 2022
- Application: ANDA212601
- Marketing authorisation holder: ALEMBIC
- Local brand name: ENTACAPONE
- Indication: TABLET — ORAL
- Status: approved
Comtan® 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 Comtan® approved in United States?
Yes. FDA authorised it on 16 July 2012; FDA authorised it on 16 August 2012; FDA authorised it on 19 June 2015.
Who is the marketing authorisation holder for Comtan® in United States?
SUN PHARM holds the US marketing authorisation.