FDA — authorised 11 September 1992
- Marketing authorisation holder: JANSSEN PHARMS
- Status: approved
🇺🇸 Sporanox in United States
FDA authorised Sporanox on 11 September 1992
Marketing authorisations
FDA — authorised 26 May 2023
- Application: ANDA212239
- Marketing authorisation holder: ANNORA PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 29 January 2024
- Application: ANDA209460
- Marketing authorisation holder: TORRENT
- Indication: Labeling
- Status: approved
The FDA approved Sporanox for labeling indications on January 29, 2024. This approval was granted to TORRENT under the standard expedited pathway. The application number for this approval is ANDA209460.
FDA — authorised 25 October 2024
- Application: NDA208901
- Marketing authorisation holder: MAYNE PHARMA
- Indication: Labeling
- Status: approved
The FDA approved Sporanox, manufactured by Mayne Pharma, for its approved labeling indication on October 25, 2024. This approval was granted through the standard expedited pathway. The application number for this approval is NDA208901.
FDA — authorised 12 March 2025
- Application: ANDA208591
- Marketing authorisation holder: ALKEM LABS LTD
- Indication: Labeling
- Status: approved
ALKEM LABS LTD received marketing authorisation from the FDA for Sporanox on 12 March 2025. The approval was granted under application number ANDA208591. The indication approved for Sporanox is listed in the labelling.
FDA — authorised 15 August 2025
- Application: ANDA205724
- Marketing authorisation holder: RISING
- Indication: Labeling
- Status: approved
The FDA approved Sporanox for labeling indications on August 15, 2025. This approval was granted to RISING under the standard expedited pathway. The application number for this approval is ANDA205724.
Sporanox in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Sporanox approved in United States?
Yes. FDA authorised it on 11 September 1992; FDA authorised it on 26 May 2023; FDA authorised it on 29 January 2024.
Who is the marketing authorisation holder for Sporanox in United States?
JANSSEN PHARMS holds the US marketing authorisation.