FDA — authorised 2 July 1999
- Status: approved
🇺🇸 Zaditor in United States
FDA authorised Zaditor on 2 July 1999
Marketing authorisations
FDA — authorised 2 July 1999
- Application: NDA021066
- Marketing authorisation holder: ALCON PHARMA
- Local brand name: ZADITOR
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 18 April 2007
- Application: NDA021996
- Marketing authorisation holder: BAUSCH AND LOMB
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 19 February 2014
- Application: ANDA077958
- Marketing authorisation holder: SENTISS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 16 September 2015
- Application: ANDA077200
- Marketing authorisation holder: ALCON PHARMS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 1 June 2020
- Application: ANDA204059
- Marketing authorisation holder: UNICHEM
- Status: approved
Zaditor in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Ophthalmology approved in United States
Frequently asked questions
Is Zaditor approved in United States?
Yes. FDA authorised it on 2 July 1999; FDA authorised it on 2 July 1999; FDA authorised it on 18 April 2007.
Who is the marketing authorisation holder for Zaditor in United States?
Marketing authorisation holder not available in our data.