FDA — authorised 22 April 2010
- Application: ANDA090547
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: VORICONAZOLE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Azole in United States
FDA authorised Azole on 22 April 2010
Marketing authorisations
FDA — authorised 30 May 2012
- Application: ANDA090862
- Marketing authorisation holder: SANDOZ INC
- Local brand name: VORICONAZOLE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 22 January 2016
- Application: ANDA206837
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: VORICONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 March 2016
- Application: ANDA206398
- Marketing authorisation holder: ALMAJECT
- Local brand name: VORICONAZOLE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 13 April 2016
- Application: ANDA205034
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: VORICONAZOLE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 24 May 2016
- Application: ANDA206762
- Marketing authorisation holder: RISING
- Local brand name: VORICONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 May 2016
- Application: ANDA206747
- Marketing authorisation holder: CADILA
- Local brand name: VORICONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2016
- Application: ANDA206799
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: VORICONAZOLE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 7 September 2016
- Application: ANDA207049
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: VORICONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 March 2017
- Application: NDA208562
- Marketing authorisation holder: HIKMA
- Local brand name: VORICONAZOLE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 July 2018
- Application: ANDA208983
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: VORICONAZOLE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 30 November 2018
- Application: ANDA211661
- Marketing authorisation holder: SLATE RUN PHARMA
- Local brand name: VORICONAZOLE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 31 March 2020
- Application: ANDA211099
- Marketing authorisation holder: GLAND
- Local brand name: VORICONAZOLE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 31 May 2021
- Application: NDA214770
- Marketing authorisation holder: MSD MERCK CO
- Local brand name: NOXAFIL POWDERMIX KIT
- Indication: FOR SUSPENSION, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 4 February 2022
- Application: ANDA214476
- Marketing authorisation holder: BIOCON PHARMA
- Local brand name: POSACONAZOLE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 7 April 2022
- Application: ANDA212500
- Marketing authorisation holder: DR REDDYS
- Local brand name: POSACONAZOLE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 8 December 2022
- Application: ANDA214321
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: POSACONAZOLE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 2 February 2023
- Application: ANDA212162
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: VORICONAZOLE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 28 August 2023
- Application: ANDA216488
- Marketing authorisation holder: I 3 PHARMS
- Local brand name: POSACONAZOLE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 26 December 2023
- Application: ANDA211500
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: POSACONAZOLE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 26 December 2023
- Application: ANDA209983
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: POSACONAZOLE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 26 December 2023
- Application: ANDA214842
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: POSACONAZOLE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 23 April 2025
- Application: ANDA217720
- Marketing authorisation holder: QILU PHARM HAINAN
- Local brand name: POSACONAZOLE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 14 November 2025
- Application: ANDA220043
- Marketing authorisation holder: HAINAN POLY PHARM
- Local brand name: VORICONAZOLE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 5 May 2026
- Application: ANDA220078
- Marketing authorisation holder: ZHEJIANG NOVUS
- Local brand name: VORICONAZOLE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA
- Application: ANDA217709
- Marketing authorisation holder: HAINAN POLY PHARM
- Local brand name: POSACONAZOLE
- Indication: INJECTION — SOLUTION
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Azole approved in United States?
Yes. FDA authorised it on 22 April 2010; FDA authorised it on 30 May 2012; FDA authorised it on 22 January 2016.
Who is the marketing authorisation holder for Azole in United States?
MYLAN PHARMS INC holds the US marketing authorisation.