FDA — authorised 7 August 2006
- Application: NDA050804
- Marketing authorisation holder: BAUSCH AND LOMB
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Loteprednol Etabonate in United States
FDA authorised Loteprednol Etabonate on 7 August 2006
Marketing authorisations
FDA — authorised 22 August 2018
- Application: NDA210565
- Marketing authorisation holder: ALCON LABS INC
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 22 February 2019
- Application: NDA208219
- Marketing authorisation holder: BAUSCH AND LOMB INC
- Local brand name: LOTEMAX SM
- Indication: GEL — OPHTHALMIC
- Status: approved
FDA — authorised 17 April 2019
- Application: ANDA207609
- Marketing authorisation holder: SENTISS
- Local brand name: LOTEPREDNOL ETABONATE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 10 February 2021
- Application: ANDA212080
- Marketing authorisation holder: SENTISS
- Local brand name: LOTEPREDNOL ETABONATE
- Indication: GEL — OPHTHALMIC
- Status: approved
FDA — authorised 26 February 2021
- Application: ANDA212450
- Marketing authorisation holder: SUN PHARM
- Local brand name: LOTEPREDNOL ETABONATE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 29 November 2023
- Application: ANDA213956
- Marketing authorisation holder: HIKMA
- Local brand name: LOTEPREDNOL ETABONATE
- Indication: GEL — OPHTHALMIC
- Status: approved
FDA — authorised 26 December 2023
- Application: ANDA215550
- Marketing authorisation holder: LUPIN
- Local brand name: LOTEPREDNOL ETABONATE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 24 April 2024
- Application: ANDA215719
- Marketing authorisation holder: LUPIN
- Local brand name: LOTEPREDNOL ETABONATE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 10 July 2024
- Application: ANDA215203
- Marketing authorisation holder: PADAGIS US
- Local brand name: LOTEPREDNOL ETABONATE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 13 December 2024
- Application: ANDA216345
- Marketing authorisation holder: AMNEAL
- Status: approved
FDA — authorised 29 January 2025
- Application: ANDA215204
- Marketing authorisation holder: PADAGIS US
- Local brand name: LOTEPREDNOL ETABONATE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 20 May 2025
- Application: ANDA217484
- Marketing authorisation holder: AMNEAL
- Local brand name: LOTEPREDNOL ETABONATE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 10 December 2025
- Application: ANDA217597
- Marketing authorisation holder: ALEMBIC
- Status: approved
FDA
- Marketing authorisation holder: ALCON LABS INC
- Status: approved
Loteprednol Etabonate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Loteprednol Etabonate approved in United States?
Yes. FDA authorised it on 7 August 2006; FDA authorised it on 22 August 2018; FDA authorised it on 22 February 2019.
Who is the marketing authorisation holder for Loteprednol Etabonate in United States?
BAUSCH AND LOMB holds the US marketing authorisation.