FDA — authorised 9 March 1998
- Application: NDA020841
- Marketing authorisation holder: PHARMOS
- Local brand name: LOTEMAX
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 Loteprednol Etabonate 0.5% in United States
FDA authorised Loteprednol Etabonate 0.5% on 9 March 1998
Marketing authorisations
FDA — authorised 15 April 2011
- Application: NDA200738
- Marketing authorisation holder: BAUSCH AND LOMB
- Local brand name: LOTEMAX
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 28 September 2012
- Application: NDA202872
- Marketing authorisation holder: BAUSCH AND LOMB INC
- Local brand name: LOTEMAX
- Indication: GEL — OPHTHALMIC
- Status: approved
Other Ophthalmology approved in United States
Frequently asked questions
Is Loteprednol Etabonate 0.5% approved in United States?
Yes. FDA authorised it on 9 March 1998; FDA authorised it on 15 April 2011; FDA authorised it on 28 September 2012.
Who is the marketing authorisation holder for Loteprednol Etabonate 0.5% in United States?
PHARMOS holds the US marketing authorisation.