🇺🇸 Ophthalmic Emulsion in United States

FDA authorised Ophthalmic Emulsion on 16 November 2022 · 25 US adverse-event reports

Marketing authorisation

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 — 5 reports (20%)
  2. Vision Blurred — 4 reports (16%)
  3. Conjunctival Erosion — 2 reports (8%)
  4. Disease Progression — 2 reports (8%)
  5. Dizziness — 2 reports (8%)
  6. Eye Irritation — 2 reports (8%)
  7. Fall — 2 reports (8%)
  8. Feeling Hot — 2 reports (8%)
  9. Insomnia — 2 reports (8%)
  10. Mood Altered — 2 reports (8%)

Source database →

Other Ophthalmology approved in United States

Frequently asked questions

Is Ophthalmic Emulsion approved in United States?

Yes. FDA authorised it on 16 November 2022.

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

DR REDDYS holds the US marketing authorisation.