FDA — authorised 21 August 2019
- Application: ANDA212411
- Marketing authorisation holder: SINOTHERAPEUTICS INC
- Local brand name: POSACONAZOLE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
🇺🇸 POSACONAZOLE in United States
FDA authorised POSACONAZOLE on 21 August 2019 · 7,126 US adverse-event reports
Marketing authorisations
FDA — authorised 15 May 2020
- Application: ANDA208773
- Marketing authorisation holder: HIKMA
- Local brand name: POSACONAZOLE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 1 February 2021
- Application: ANDA213454
- Marketing authorisation holder: AET PHARMA
- 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 10 May 2022
- Application: ANDA212226
- Marketing authorisation holder: SPECGX LLC
- Local brand name: POSACONAZOLE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 25 May 2022
- Application: ANDA208768
- Marketing authorisation holder: PH HEALTH
- Local brand name: POSACONAZOLE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 30 November 2022
- Application: ANDA207355
- Marketing authorisation holder: ACTAVIS LABS FL INC
- 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 22 December 2022
- Application: ANDA216626
- Marketing authorisation holder: AMNEAL
- Local brand name: POSACONAZOLE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 20 June 2023
- Application: ANDA216326
- Marketing authorisation holder: WELDING
- Local brand name: POSACONAZOLE
- Indication: TABLET, DELAYED RELEASE — ORAL
- 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: ANDA217553
- Marketing authorisation holder: GLAND
- 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 26 December 2023
- Application: ANDA211500
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: POSACONAZOLE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 18 July 2024
- Application: ANDA217119
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: POSACONAZOLE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 23 December 2024
- Application: ANDA219057
- Marketing authorisation holder: ASPIRO
- Local brand name: POSACONAZOLE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 24 February 2025
- Application: ANDA218434
- Marketing authorisation holder: MSN
- Local brand name: POSACONAZOLE
- Indication: TABLET, DELAYED RELEASE — ORAL
- 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
- Status: approved
FDA
- Application: ANDA217709
- Marketing authorisation holder: HAINAN POLY PHARM
- Local brand name: POSACONAZOLE
- Indication: INJECTION — SOLUTION
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 7,126
Most-reported reactions
- Drug Ineffective — 1,268 reports (17.79%)
- Off Label Use — 1,111 reports (15.59%)
- Febrile Neutropenia — 864 reports (12.12%)
- Drug Interaction — 732 reports (10.27%)
- Pyrexia — 627 reports (8.8%)
- Neutropenia — 619 reports (8.69%)
- Death — 554 reports (7.77%)
- Product Use In Unapproved Indication — 486 reports (6.82%)
- Pneumonia — 470 reports (6.6%)
- Thrombocytopenia — 395 reports (5.54%)
POSACONAZOLE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is POSACONAZOLE approved in United States?
Yes. FDA authorised it on 21 August 2019; FDA authorised it on 15 May 2020; FDA authorised it on 1 February 2021.
Who is the marketing authorisation holder for POSACONAZOLE in United States?
SINOTHERAPEUTICS INC holds the US marketing authorisation.