FDA
- Application: NDA016948
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: BENDOPA
- Indication: CAPSULE — ORAL
- Status: approved
L-DOPA/DDCI (L-DOPA/DDCI) 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.
VALEANT PHARM INTL holds the US marketing authorisation.