🇺🇸 NAFT500 (pediatric) in United States

FDA authorised NAFT500 (pediatric) on 8 September 2016

Marketing authorisations

FDA — authorised 8 September 2016

  • Application: ANDA205975
  • Marketing authorisation holder: SUN PHARMA CANADA
  • Local brand name: NAFTIFINE HYDROCHLORIDE
  • Indication: CREAM — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 10 April 2019

  • Application: ANDA208201
  • Marketing authorisation holder: SUN PHARMA CANADA
  • Local brand name: NAFTIFINE HYDROCHLORIDE
  • Indication: GEL — TOPICAL
  • Status: approved

Read official source →

FDA — authorised 22 September 2020

  • Application: ANDA210038
  • Marketing authorisation holder: XIROMED
  • Local brand name: NAFTIFINE HYDROCHLORIDE
  • Indication: CREAM — TOPICAL
  • Status: approved

Read official source →

Other Dermatology / Infectious Disease approved in United States

Frequently asked questions

Is NAFT500 (pediatric) approved in United States?

Yes. FDA authorised it on 8 September 2016; FDA authorised it on 10 April 2019; FDA authorised it on 22 September 2020.

Who is the marketing authorisation holder for NAFT500 (pediatric) in United States?

SUN PHARMA CANADA holds the US marketing authorisation.