FDA — authorised 30 August 1985
- Application: NDA019270
- Marketing authorisation holder: SANDOZ
- Local brand name: BETOPTIC
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 Betoptic in United States
FDA authorised Betoptic on 30 August 1985
Marketing authorisations
FDA — authorised 2 November 1999
- Application: ANDA075541
- Marketing authorisation holder: EPIC PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 27 June 2008
- Application: ANDA078962
- Marketing authorisation holder: KVK TECH
- Status: approved
FDA — authorised 24 March 2016
- Application: NDA019845
- Marketing authorisation holder: NOVARTIS
- Indication: Manufacturing (CMC)
- Status: approved
Betoptic in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Betoptic approved in United States?
Yes. FDA authorised it on 30 August 1985; FDA authorised it on 2 November 1999; FDA authorised it on 27 June 2008.
Who is the marketing authorisation holder for Betoptic in United States?
SANDOZ holds the US marketing authorisation.