🇺🇸 DOCETAXEL in United States

FDA authorised DOCETAXEL on 8 June 2011 · 62,585 US adverse-event reports

Marketing authorisations

FDA — authorised 8 June 2011

  • Application: NDA201195
  • Marketing authorisation holder: ACCORD HLTHCARE
  • Status: supplemented

FDA — authorised 9 August 2017

  • Application: ANDA207252
  • Marketing authorisation holder: HENGRUI PHARMA
  • Status: supplemented

FDA — authorised 6 July 2018

  • Application: ANDA210848
  • Marketing authorisation holder: MYLAN LABS LTD
  • Status: supplemented

FDA — authorised 25 June 2021

  • Application: ANDA214575
  • Marketing authorisation holder: EUGIA PHARMA
  • Status: approved

FDA — authorised 13 May 2025

  • Application: ANDA213768
  • Marketing authorisation holder: GUANGDONG SUNHO
  • Status: approved

FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Alopecia — 17,957 reports (28.69%)
  2. Madarosis — 6,852 reports (10.95%)
  3. Hair Texture Abnormal — 6,130 reports (9.79%)
  4. Hair Colour Changes — 6,011 reports (9.6%)
  5. Hair Disorder — 5,644 reports (9.02%)
  6. Diarrhoea — 5,429 reports (8.67%)
  7. Nausea — 3,941 reports (6.3%)
  8. Emotional Distress — 3,616 reports (5.78%)
  9. Neutropenia — 3,520 reports (5.62%)
  10. Anxiety — 3,485 reports (5.57%)

Source database →

DOCETAXEL 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 DOCETAXEL approved in United States?

Yes. FDA authorised it on 8 June 2011; FDA authorised it on 9 August 2017; FDA authorised it on 6 July 2018.

Who is the marketing authorisation holder for DOCETAXEL in United States?

ACCORD HLTHCARE holds the US marketing authorisation.