FDA — authorised 11 September 1992
- Application: NDA020083
- Marketing authorisation holder: JANSSEN PHARMS
- Status: supplemented
FDA authorised Sporanox on 11 September 1992
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 11 September 1992; FDA has authorised it.
JANSSEN PHARMS holds the US marketing authorisation.