FDA — authorised 17 August 1978
- Application: NDA018086
- Marketing authorisation holder: BAUSCH AND LOMB INC
- Local brand name: TIMOPTIC
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 timolol maleate 0.5% in United States
FDA authorised timolol maleate 0.5% on 17 August 1978
Marketing authorisations
FDA — authorised 4 November 1993
- Application: NDA020330
- Marketing authorisation holder: BAUSCH AND LOMB INC
- Local brand name: TIMOPTIC-XE
- Indication: SOLUTION, GEL FORMING/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 31 March 1995
- Application: NDA020439
- Marketing authorisation holder: THEA PHARMA
- Local brand name: BETIMOL
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Status: approved
timolol maleate 0.5% in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is timolol maleate 0.5% approved in United States?
Yes. FDA authorised it on 17 August 1978; FDA authorised it on 4 November 1993; FDA authorised it on 31 March 1995.
Who is the marketing authorisation holder for timolol maleate 0.5% in United States?
BAUSCH AND LOMB INC holds the US marketing authorisation.