FDA — authorised 30 April 2001
- Application: ANDA075796
- Marketing authorisation holder: DURAMED PHARMS BARR
- Status: supplemented
FDA authorised Aviane on 30 April 2001
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 30 April 2001; FDA has authorised it.
DURAMED PHARMS BARR holds the US marketing authorisation.