🇺🇸 Difluprednate Ophthalmic in United States

FDA authorised Difluprednate Ophthalmic on 23 June 2008 · 8 US adverse-event reports

Marketing authorisations

FDA — authorised 23 June 2008

  • Application: NDA022212
  • Marketing authorisation holder: SANDOZ
  • Status: supplemented

FDA — authorised 16 November 2022

  • Application: ANDA214894
  • Marketing authorisation holder: DR REDDYS
  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Drug Ineffective — 3 reports (37.5%)
  2. Eyelid Ptosis — 1 report (12.5%)
  3. Mood Altered — 1 report (12.5%)
  4. Nausea — 1 report (12.5%)
  5. Ocular Hypertension — 1 report (12.5%)
  6. Visual Impairment — 1 report (12.5%)

Source database →

Other Ophthalmology approved in United States

Frequently asked questions

Is Difluprednate Ophthalmic approved in United States?

Yes. FDA authorised it on 23 June 2008; FDA authorised it on 16 November 2022.

Who is the marketing authorisation holder for Difluprednate Ophthalmic in United States?

SANDOZ holds the US marketing authorisation.