FDA — authorised 3 July 1986
- Application: ANDA088373
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: CYCLOPHOSPHAMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 FEC-D in United States
FDA authorised FEC-D on 3 July 1986
Marketing authorisations
FDA — authorised 3 July 1986
- Application: ANDA088372
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: CYCLOPHOSPHAMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 July 1986
- Application: ANDA088371
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: CYCLOPHOSPHAMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 August 1999
- Application: ANDA040032
- Marketing authorisation holder: ROXANE
- Local brand name: CYCLOPHOSPHAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 March 2011
- Application: NDA022234
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 May 2011
- Application: NDA022534
- Marketing authorisation holder: SUN PHARM
- Local brand name: DOCEFREZ
- 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 12 April 2013
- Application: NDA203551
- Marketing authorisation holder: ACTAVIS
- 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 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 25 May 2018
- Application: ANDA210046
- Marketing authorisation holder: AMNEAL
- Local brand name: CYCLOPHOSPHAMIDE
- 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 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 30 July 2020
- Application: NDA212501
- Marketing authorisation holder: DR REDDYS
- Local brand name: CYCLOPHOSPHAMIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 14 January 2021
- Application: ANDA204490
- Marketing authorisation holder: HIKMA
- 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 25 August 2021
- Application: NDA210735
- Marketing authorisation holder: EUGIA PHARMA SPECLTS
- Local brand name: CYCLOPHOSPHAMIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 18 October 2022
- Application: ANDA211757
- Marketing authorisation holder: XGEN PHARMS
- Local brand name: CYCLOPHOSPHAMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 February 2023
- Application: ANDA215744
- Marketing authorisation holder: ALEMBIC
- Local brand name: DOCETAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 October 2023
- Application: ANDA215089
- Marketing authorisation holder: SUNNY
- Local brand name: CYCLOPHOSPHAMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 December 2023
- Application: ANDA216958
- Marketing authorisation holder: HIKMA
- Local brand name: CYCLOPHOSPHAMIDE
- 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 3 December 2024
- Application: ANDA218282
- Marketing authorisation holder: EIRGEN
- Local brand name: CYCLOPHOSPHAMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 December 2024
- Application: ANDA218644
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: CYCLOPHOSPHAMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 December 2024
- Application: ANDA218632
- Marketing authorisation holder: HAINAN POLY
- Local brand name: CYCLOPHOSPHAMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
FEC-D in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is FEC-D approved in United States?
Yes. FDA authorised it on 3 July 1986; FDA authorised it on 3 July 1986; FDA authorised it on 3 July 1986.
Who is the marketing authorisation holder for FEC-D in United States?
BAXTER HLTHCARE holds the US marketing authorisation.