FDA — authorised 9 June 1999
- Marketing authorisation holder: GENZYME CORP
- Status: approved
🇺🇸 Hectorol in United States
FDA authorised Hectorol on 9 June 1999
Marketing authorisations
FDA — authorised 23 September 2011
- Application: ANDA091433
- Marketing authorisation holder: HIKMA
- Local brand name: DOXERCALCIFEROL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 August 2013
- Application: ANDA091101
- Marketing authorisation holder: HIKMA
- Local brand name: DOXERCALCIFEROL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 February 2014
- Application: ANDA200926
- Marketing authorisation holder: CAPLIN
- Local brand name: DOXERCALCIFEROL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 May 2015
- Application: ANDA203929
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: DOXERCALCIFEROL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 September 2016
- Application: ANDA201518
- Marketing authorisation holder: RISING
- Local brand name: DOXERCALCIFEROL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 May 2017
- Application: ANDA208975
- Marketing authorisation holder: AMNEAL
- Local brand name: DOXERCALCIFEROL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 May 2017
- Application: ANDA208974
- Marketing authorisation holder: AMNEAL
- Local brand name: DOXERCALCIFEROL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 November 2018
- Application: ANDA210801
- Marketing authorisation holder: LUPIN
- Local brand name: DOXERCALCIFEROL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 September 2019
- Application: ANDA210452
- Marketing authorisation holder: GLAND
- Local brand name: DOXERCALCIFEROL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 February 2020
- Application: ANDA211670
- Marketing authorisation holder: MEITHEAL
- Local brand name: DOXERCALCIFEROL
- Indication: INJECTABLE — INJECTION
- Status: approved
Hectorol in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Hectorol approved in United States?
Yes. FDA authorised it on 9 June 1999; FDA authorised it on 23 September 2011; FDA authorised it on 30 August 2013.
Who is the marketing authorisation holder for Hectorol in United States?
GENZYME CORP holds the US marketing authorisation.