FDA
- Status: approved
Budesonide, Formoterol Fumarate Dihydrate (Budesonide, Formoterol Fumarate Dihydrate) regulatory status in United States.
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA has authorised it.
Teva Pharma GmbH is the originator. The local marketing authorisation holder may differ — check the official source linked above.