FDA — authorised 19 October 1999
- Marketing authorisation holder: ORION PHARMA
- Status: approved
🇺🇸 Comtan in United States
FDA authorised Comtan on 19 October 1999
Marketing authorisations
FDA — authorised 2 February 2009
- Application: NDA020796
- Marketing authorisation holder: ORION PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 19 June 2015
- Application: ANDA203437
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Status: approved
FDA — authorised 31 August 2017
- Application: ANDA205792
- Marketing authorisation holder: AJANTA PHARMA LTD
- Status: approved
FDA — authorised 3 October 2018
- Application: ANDA206669
- Marketing authorisation holder: SUNSHINE
- Status: approved
FDA — authorised 4 January 2022
- Application: ANDA212601
- Marketing authorisation holder: ALEMBIC
- 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.
Other Metabolic approved in United States
Frequently asked questions
Is Comtan approved in United States?
Yes. FDA authorised it on 19 October 1999; FDA authorised it on 2 February 2009; FDA authorised it on 19 June 2015.
Who is the marketing authorisation holder for Comtan in United States?
ORION PHARMA holds the US marketing authorisation.