🇺🇸 Topical Gutt Nepafenac 0.1% in United States

FDA authorised Topical Gutt Nepafenac 0.1% on 19 August 2005

Marketing authorisations

FDA — authorised 19 August 2005

  • Application: NDA021862
  • Marketing authorisation holder: HARROW EYE
  • Local brand name: NEVANAC
  • Indication: SUSPENSION/DROPS — OPHTHALMIC
  • Status: approved

Read official source →

FDA

  • Status: approved

Topical Gutt Nepafenac 0.1% 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 Topical Gutt Nepafenac 0.1% approved in United States?

Yes. FDA authorised it on 19 August 2005; FDA has authorised it.

Who is the marketing authorisation holder for Topical Gutt Nepafenac 0.1% in United States?

HARROW EYE holds the US marketing authorisation.