FDA — authorised 17 April 1998
- Marketing authorisation holder: ABBVIE
- Status: approved
🇺🇸 Zemplar in United States
FDA authorised Zemplar on 17 April 1998
Marketing authorisations
FDA — authorised 27 July 2011
- Application: ANDA091108
- Marketing authorisation holder: SANDOZ
- Local brand name: PARICALCITOL
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 27 September 2013
- Application: ANDA090829
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: PARICALCITOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 March 2014
- Application: ANDA202539
- Marketing authorisation holder: BIONPHARMA
- Local brand name: PARICALCITOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 June 2014
- Application: ANDA202124
- Marketing authorisation holder: RISING
- Local brand name: PARICALCITOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 June 2014
- Application: ANDA091412
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: PARICALCITOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 August 2014
- Application: NDA021606
- Marketing authorisation holder: ABBVIE
- Indication: Labeling
- Status: approved
FDA — authorised 21 October 2014
- Application: NDA201657
- Marketing authorisation holder: HOSPIRA
- Local brand name: PARICALCITOL
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 18 November 2014
- Application: NDA205917
- Marketing authorisation holder: HIKMA PHARMS
- Local brand name: PARICALCITOL
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 13 January 2016
- Application: ANDA204327
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: PARICALCITOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 January 2016
- Application: ANDA207672
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Status: approved
FDA — authorised 4 February 2016
- Application: NDA207174
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: PARICALCITOL
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 24 February 2016
- Application: ANDA206710
- Marketing authorisation holder: LOTUS PHARM CO LTD
- Local brand name: PARICALCITOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 October 2016
- Application: ANDA204948
- Marketing authorisation holder: MARKSANS PHARMA
- Status: approved
FDA — authorised 9 March 2017
- Application: ANDA206699
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: PARICALCITOL
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 9 October 2018
- Application: ANDA205982
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: PARICALCITOL
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA
- Application: ANDA091583
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: PARICALCITOL
- Indication: INJECTABLE — INJECTION
- Status: approved
Zemplar in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Nephrology approved in United States
Frequently asked questions
Is Zemplar approved in United States?
Yes. FDA authorised it on 17 April 1998; FDA authorised it on 27 July 2011; FDA authorised it on 27 September 2013.
Who is the marketing authorisation holder for Zemplar in United States?
ABBVIE holds the US marketing authorisation.