FDA — authorised 12 September 1997
- Application: NDA020420
- Marketing authorisation holder: GENSIA AUTOMEDICS
- Local brand name: GENESA
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised Genesa on 12 September 1997
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 12 September 1997; FDA has authorised it.
GENSIA AUTOMEDICS holds the US marketing authorisation.