🇺🇸 loteprednol etabonate and tobramycin in United States

FDA authorised loteprednol etabonate and tobramycin on 14 December 2004

Marketing authorisations

FDA — authorised 14 December 2004

  • Application: NDA050804
  • Marketing authorisation holder: BAUSCH AND LOMB
  • Status: supplemented

FDA — authorised 10 December 2025

  • Application: ANDA217597
  • Marketing authorisation holder: ALEMBIC
  • Local brand name: LOTEPREDNOL ETABONATE AND TOBRAMYCIN
  • Indication: SUSPENSION/DROPS — OPHTHALMIC
  • Status: approved

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FDA

  • Status: approved

loteprednol etabonate and tobramycin in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is loteprednol etabonate and tobramycin approved in United States?

Yes. FDA authorised it on 14 December 2004; FDA authorised it on 10 December 2025; FDA has authorised it.

Who is the marketing authorisation holder for loteprednol etabonate and tobramycin in United States?

BAUSCH AND LOMB holds the US marketing authorisation.