FDA — authorised 12 October 2001
- Application: ANDA075765
- Marketing authorisation holder: TEVA
- Local brand name: CALCITRIOL
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 palicalcitol in United States
FDA authorised palicalcitol on 12 October 2001
Marketing authorisations
FDA — authorised 31 December 2002
- Application: ANDA075836
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CALCITRIOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 February 2003
- Application: ANDA075766
- Marketing authorisation holder: FRESENIUS MEDCL
- Local brand name: CALCITRIOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 March 2003
- Application: ANDA075823
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: CALCITRIOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 July 2003
- Application: ANDA076242
- Marketing authorisation holder: HIKMA
- Local brand name: CALCITRIOL
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 17 September 2003
- Application: ANDA076206
- Marketing authorisation holder: ROCKWELL MEDCL
- Local brand name: CALCITRIOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 September 2003
- Application: ANDA075746
- Marketing authorisation holder: AM REGENT
- Local brand name: CALCITRIOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 January 2004
- Application: ANDA075816
- Marketing authorisation holder: HOSPIRA
- Local brand name: CALCITRIOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 February 2006
- Application: ANDA077102
- Marketing authorisation holder: SAGENT PHARMS
- Local brand name: CALCITRIOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 January 2008
- Application: ANDA078066
- Marketing authorisation holder: LONG GROVE PHARMS
- Local brand name: CALCITRIOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 May 2013
- Application: ANDA091174
- Marketing authorisation holder: BIONPHARMA
- Local brand name: CALCITRIOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 June 2017
- Application: ANDA203289
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: CALCITRIOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 November 2018
- Application: ANDA209798
- Marketing authorisation holder: RISING
- Local brand name: CALCITRIOL
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 3 February 2020
- Application: ANDA211030
- Marketing authorisation holder: GLAND
- Local brand name: CALCITRIOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 July 2023
- Application: ANDA203973
- Marketing authorisation holder: ANDA REPOSITORY
- Local brand name: CALCITRIOL
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Status: approved
palicalcitol 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 palicalcitol approved in United States?
Yes. FDA authorised it on 12 October 2001; FDA authorised it on 31 December 2002; FDA authorised it on 20 February 2003.
Who is the marketing authorisation holder for palicalcitol in United States?
TEVA holds the US marketing authorisation.