FDA — authorised 16 October 2003
- Marketing authorisation holder: ALLERGAN
- Status: approved
🇺🇸 Elestat in United States
FDA authorised Elestat on 16 October 2003
Marketing authorisations
FDA — authorised 16 October 2003
- Application: NDA021565
- Marketing authorisation holder: ALLERGAN
- Local brand name: ELESTAT
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 31 October 2011
- Application: ANDA090951
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Status: approved
Elestat in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Elestat approved in United States?
Yes. FDA authorised it on 16 October 2003; FDA authorised it on 16 October 2003; FDA authorised it on 31 October 2011.
Who is the marketing authorisation holder for Elestat in United States?
ALLERGAN holds the US marketing authorisation.