🇺🇸 Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops in United States

FDA authorised Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops on 27 February 1986

Marketing authorisations

FDA — authorised 27 February 1986

  • Application: ANDA070185
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: FLUOR-OP
  • Indication: SUSPENSION/DROPS — OPHTHALMIC
  • Status: approved

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FDA

  • Status: approved

Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops 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 Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops approved in United States?

Yes. FDA authorised it on 27 February 1986; FDA has authorised it.

Who is the marketing authorisation holder for Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops in United States?

NOVARTIS holds the US marketing authorisation.