FDA — authorised 8 March 2011
- Application: NDA022234
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Taxotere in United States
FDA authorised Taxotere on 8 March 2011
Marketing authorisations
FDA — authorised 3 May 2011
- Application: NDA022534
- Marketing authorisation holder: SUN PHARM
- Local brand name: DOCEFREZ
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 June 2011
- Application: NDA201195
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 June 2011
- Application: NDA201525
- Marketing authorisation holder: SANDOZ
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 January 2012
- Application: NDA022312
- Marketing authorisation holder: APOTEX INC
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 April 2013
- Application: NDA203551
- Marketing authorisation holder: ACTAVIS
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 March 2014
- Application: NDA202356
- Marketing authorisation holder: PFIZER LABS
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 November 2014
- Application: ANDA204193
- Marketing authorisation holder: DR REDDYS
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 December 2015
- Application: NDA205934
- Marketing authorisation holder: SHILPA
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 February 2017
- Application: ANDA203170
- Marketing authorisation holder: HENGRUI PHARMA
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 August 2017
- Application: ANDA207252
- Marketing authorisation holder: HENGRUI PHARMA
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 August 2017
- Application: ANDA207563
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 January 2018
- Application: ANDA209640
- Marketing authorisation holder: AMNEAL
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 July 2018
- Application: ANDA210072
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 July 2018
- Application: ANDA210848
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
Mylan Labs Ltd received marketing authorisation for Taxotere from the US FDA on 12 January 2024. The approval was granted under application number ANDA210848, which followed a standard review pathway. Taxotere is a medication used in the treatment of various cancers, as indicated in its approved labeling.
FDA — authorised 24 August 2018
- Application: ANDA209634
- Marketing authorisation holder: MEITHEAL
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 May 2019
- Application: ANDA210327
- Marketing authorisation holder: SHILPA
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 January 2021
- Application: ANDA204490
- Marketing authorisation holder: HIKMA
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 June 2021
- Application: ANDA214575
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 July 2021
- Application: ANDA213510
- Marketing authorisation holder: GLAND
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 November 2022
- Application: NDA215813
- Marketing authorisation holder: AVYXA HOLDINGS
- Local brand name: DOCIVYX
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
The FDA approved Taxotere for labeling indications. This approval was granted to AVYXA HOLDINGS on April 11, 2024, under the standard expedited pathway. The application number for this approval is NDA215813.
FDA — authorised 28 February 2023
- Application: ANDA215744
- Marketing authorisation holder: ALEMBIC
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 February 2024
- Application: ANDA216677
- Marketing authorisation holder: HERITAGE
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 October 2024
- Application: NDA218711
- Marketing authorisation holder: ZHUHAI
- Local brand name: BEIZRAY
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 13 May 2025
- Application: ANDA213768
- Marketing authorisation holder: GUANGDONG SUNHO
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
Taxotere 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 Taxotere approved in United States?
Yes. FDA authorised it on 8 March 2011; FDA authorised it on 3 May 2011; FDA authorised it on 8 June 2011.
Who is the marketing authorisation holder for Taxotere in United States?
HOSPIRA INC holds the US marketing authorisation.