FDA
- Application: ANDA208815
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: ELTROMBOPAG
- Indication: TABLET — ORAL
- Status: approved
Revolade® (Revolade®) 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.
ACTAVIS LABS FL INC holds the US marketing authorisation.