FDA — authorised 23 June 2005
- Marketing authorisation holder: GALEN SPECIALTY
- Status: approved
🇺🇸 Tetracaine Hydrochloride in United States
FDA authorised Tetracaine Hydrochloride on 23 June 2005
Marketing authorisations
FDA — authorised 12 March 2019
- Application: NDA210821
- Marketing authorisation holder: BAUSCH LOMB IRELAND
- Local brand name: TETRACAINE HYDROCHLORIDE
- Indication: SOLUTION — OPHTHALMIC
- Status: approved
Tetracaine Hydrochloride in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Tetracaine Hydrochloride approved in United States?
Yes. FDA authorised it on 23 June 2005; FDA authorised it on 12 March 2019.
Who is the marketing authorisation holder for Tetracaine Hydrochloride in United States?
GALEN SPECIALTY holds the US marketing authorisation.