FDA — authorised 6 January 2016
- Application: ANDA206901
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: NAFTIFINE HYDROCHLORIDE
- Indication: CREAM — TOPICAL
- Status: approved
🇺🇸 NAFT600 (pediatric) in United States
FDA authorised NAFT600 (pediatric) on 6 January 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
FDA — authorised 10 April 2017
- Application: ANDA206960
- Marketing authorisation holder: AMNEAL
- Local brand name: NAFTIFINE HYDROCHLORIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 20 March 2019
- Application: ANDA206165
- Marketing authorisation holder: AMNEAL
- Local brand name: NAFTIFINE HYDROCHLORIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 10 April 2019
- Application: ANDA208201
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: NAFTIFINE HYDROCHLORIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 22 September 2020
- Application: ANDA210038
- Marketing authorisation holder: XIROMED
- Local brand name: NAFTIFINE HYDROCHLORIDE
- Indication: CREAM — TOPICAL
- Status: approved
Other Dermatology approved in United States
Frequently asked questions
Is NAFT600 (pediatric) approved in United States?
Yes. FDA authorised it on 6 January 2016; FDA authorised it on 8 September 2016; FDA authorised it on 10 April 2017.
Who is the marketing authorisation holder for NAFT600 (pediatric) in United States?
SUN PHARMA CANADA holds the US marketing authorisation.