FDA — authorised 5 June 1996
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Status: approved
🇺🇸 Xalatan in United States
FDA authorised Xalatan on 5 June 1996
Marketing authorisations
FDA — authorised 5 June 1996
- Application: NDA020597
- Marketing authorisation holder: UPJOHN
- Local brand name: XALATAN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 22 March 2011
- Application: ANDA091449
- Marketing authorisation holder: SANDOZ
- Local brand name: LATANOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 22 March 2011
- Application: ANDA077697
- Marketing authorisation holder: APOTEX INC
- Local brand name: LATANOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 22 March 2011
- Application: ANDA200925
- Marketing authorisation holder: AMRING PHARMS
- Local brand name: LATANOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 22 March 2011
- Application: ANDA201786
- Marketing authorisation holder: SOMERSET
- Local brand name: LATANOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 22 March 2011
- Application: ANDA201006
- Marketing authorisation holder: BAUSCH AND LOMB
- Local brand name: LATANOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 19 July 2011
- Application: ANDA090887
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: LATANOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 22 April 2016
- Application: ANDA202442
- Marketing authorisation holder: FDC LTD
- Local brand name: LATANOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 3 September 2019
- Application: ANDA206519
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: LATANOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 13 December 2022
- Application: NDA216472
- Marketing authorisation holder: THEA PHARMA
- Local brand name: IYUZEH
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 26 November 2024
- Application: ANDA218257
- Marketing authorisation holder: GLAND
- Local brand name: LATANOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 14 April 2025
- Application: ANDA219306
- Marketing authorisation holder: MICRO LABS
- Local brand name: LATANOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 17 December 2025
- Application: ANDA220360
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: LATANOPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA076218
- Marketing authorisation holder: PAR PHARM
- Local brand name: LATANOPROST
- Indication: SOLUTION — OPHTHALMIC
- Status: approved
Xalatan 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 Xalatan approved in United States?
Yes. FDA authorised it on 5 June 1996; FDA authorised it on 5 June 1996; FDA authorised it on 22 March 2011.
Who is the marketing authorisation holder for Xalatan in United States?
PHARMACIA AND UPJOHN holds the US marketing authorisation.