FDA — authorised 6 June 1963
- Application: NDA050023
- Marketing authorisation holder: HARROW EYE
- Local brand name: MAXITROL
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 Maxitrol® in United States
FDA authorised Maxitrol® on 6 June 1963
Marketing authorisations
FDA — authorised 19 July 1963
- Application: NDA050065
- Marketing authorisation holder: SANDOZ
- Local brand name: MAXITROL
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 22 May 1984
- Application: ANDA062341
- Marketing authorisation holder: SANDOZ
- Local brand name: MAXITROL
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
Other Ophthalmology approved in United States
Frequently asked questions
Is Maxitrol® approved in United States?
Yes. FDA authorised it on 6 June 1963; FDA authorised it on 19 July 1963; FDA authorised it on 22 May 1984.
Who is the marketing authorisation holder for Maxitrol® in United States?
HARROW EYE holds the US marketing authorisation.