FDA — authorised 26 May 2023
- Application: ANDA212239
- Marketing authorisation holder: ANNORA PHARMA
- Indication: Labeling
- Status: approved
🇺🇸 ITRACONAZOLE in United States
FDA authorised ITRACONAZOLE on 26 May 2023
Marketing authorisations
FDA — authorised 29 January 2024
- Application: ANDA209460
- Marketing authorisation holder: TORRENT
- Indication: Labeling
- Status: approved
The FDA approved ITRACONAZOLE for use in the United States on 2024-01-29. The marketing authorisation was granted to TORRENT under application number ANDA209460. The approval was made through the standard expedited pathway.
FDA — authorised 25 October 2024
- Application: NDA208901
- Marketing authorisation holder: MAYNE PHARMA
- Indication: Labeling
- Status: approved
The FDA approved ITRACONAZOLE for use in the United States on 2024-10-25. The marketing authorisation holder is MAYNE PHARMA. The application was submitted under the standard expedited pathway. The approved indication is for labeling, but the specific details of the indication are not reported in the available data.
FDA — authorised 12 March 2025
- Application: ANDA208591
- Marketing authorisation holder: ALKEM LABS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 15 August 2025
- Application: ANDA205724
- Marketing authorisation holder: RISING
- Indication: Labeling
- Status: approved
The FDA approved ITRACONAZOLE for labelling indications on 15 August 2025. The marketing authorisation holder is RISING. The application number for this approval is ANDA205724. ITRACONAZOLE was approved under the standard expedited pathway.
ITRACONAZOLE 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 ITRACONAZOLE approved in United States?
Yes. FDA authorised it on 26 May 2023; FDA authorised it on 29 January 2024; FDA authorised it on 25 October 2024.
Who is the marketing authorisation holder for ITRACONAZOLE in United States?
ANNORA PHARMA holds the US marketing authorisation.