FDA — authorised 18 August 1995
- Application: NDA020213
- Marketing authorisation holder: BAUSCH AND LOMB
- Indication: Labeling
- Status: approved
🇺🇸 Miochol-E in United States
FDA authorised Miochol-E on 18 August 1995
Marketing authorisation
Miochol-E 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 Miochol-E approved in United States?
Yes. FDA authorised it on 18 August 1995.
Who is the marketing authorisation holder for Miochol-E in United States?
BAUSCH AND LOMB holds the US marketing authorisation.