FDA — authorised 31 October 2002
- Application: NDA021454
- Marketing authorisation holder: ENDO OPERATIONS
- Local brand name: TESTIM
- Indication: GEL — TRANSDERMAL
- Status: approved
FDA authorised Testim on 31 October 2002
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 31 October 2002; FDA has authorised it.
ENDO OPERATIONS holds the US marketing authorisation.