FDA — authorised 31 October 1985
- Application: NDA018830
- Marketing authorisation holder: ALVOGEN
- Local brand name: TAMBOCOR
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Tambocor in United States
FDA authorised Tambocor on 31 October 1985
Marketing authorisations
FDA — authorised 31 October 1985
- Status: approved
FDA — authorised 31 July 2001
- Application: ANDA075442
- Marketing authorisation holder: AMNEAL PHARM
- Status: approved
FDA — authorised 9 July 2009
- Application: ANDA079164
- Marketing authorisation holder: CHARTWELL
- Status: approved
FDA — authorised 3 November 2017
- Application: ANDA202821
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Status: approved
FDA — authorised 16 September 2020
- Application: ANDA210683
- Marketing authorisation holder: REGCON HOLDINGS
- Status: approved
FDA — authorised 8 September 2022
- Application: ANDA215599
- Marketing authorisation holder: YICHANG HUMANWELL
- Status: approved
Tambocor 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 Tambocor approved in United States?
Yes. FDA authorised it on 31 October 1985; FDA authorised it on 31 October 1985; FDA authorised it on 31 July 2001.
Who is the marketing authorisation holder for Tambocor in United States?
ALVOGEN holds the US marketing authorisation.