FDA
- Application: ANDA213092
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: LENVATINIB
- Indication: CAPSULE — ORAL
- Status: approved
E7080 capsule (E7080 capsule) 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.
SUN PHARM INDS INC holds the US marketing authorisation.