FDA — authorised 10 September 1985
- Application: ANDA062560
- Marketing authorisation holder: LILLY
- Local brand name: MANDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised Kefadol on 10 September 1985
Yes. FDA authorised it on 10 September 1985; FDA has authorised it.
LILLY holds the US marketing authorisation.