FDA — authorised 22 January 2014
- Application: ANDA203395
- Marketing authorisation holder: SENTISS
- Status: approved
🇺🇸 Xibrom in United States
FDA authorised Xibrom on 22 January 2014
Marketing authorisations
FDA — authorised 8 April 2016
- Application: NDA206911
- Marketing authorisation holder: SUN PHARM
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 21 June 2019
- Application: ANDA210560
- Marketing authorisation holder: ALEMBIC
- Status: approved
FDA — authorised 2 February 2024
- Application: ANDA211239
- Marketing authorisation holder: LUPIN LTD
- Status: approved
FDA — authorised 8 July 2024
- Application: ANDA207334
- Marketing authorisation holder: APOTEX
- Status: approved
Xibrom 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 Xibrom approved in United States?
Yes. FDA authorised it on 22 January 2014; FDA authorised it on 8 April 2016; FDA authorised it on 21 June 2019.
Who is the marketing authorisation holder for Xibrom in United States?
SENTISS holds the US marketing authorisation.