FDA — authorised 21 July 2015
- Application: NDA021660
- Marketing authorisation holder: BRISTOL-MYERS
- Indication: Labeling
- Status: approved
🇺🇸 Taxol in United States
FDA authorised Taxol on 21 July 2015
Marketing authorisations
FDA — authorised 23 August 2016
- Application: ANDA207326
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 27 July 2022
- Application: NDA211875
- Marketing authorisation holder: AM REGENT
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 11 May 2023
- Application: NDA216338
- Marketing authorisation holder: TEVA PHARMS INC
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 15 May 2025
- Application: ANDA216355
- Marketing authorisation holder: SHUANGCHENG
- Status: approved
Taxol in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Taxol approved in United States?
Yes. FDA authorised it on 21 July 2015; FDA authorised it on 23 August 2016; FDA authorised it on 27 July 2022.
Who is the marketing authorisation holder for Taxol in United States?
BRISTOL-MYERS holds the US marketing authorisation.