FDA — authorised 1 March 2004
- Application: NDA021571
- Marketing authorisation holder: SANTEN
- Local brand name: IQUIX
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA authorised 1.5% levofloxacin ophthalmic solution on 1 March 2004
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 1 March 2004; FDA has authorised it.
SANTEN holds the US marketing authorisation.