FDA — authorised 29 September 2000
- Application: NDA021184
- Marketing authorisation holder: ALMIRALL
- Local brand name: AVAGE
- Indication: CREAM — TOPICAL
- Status: approved
🇺🇸 Tazarotene Cream 0.05% in United States
FDA authorised Tazarotene Cream 0.05% on 29 September 2000
Marketing authorisations
FDA — authorised 3 April 2017
- Application: ANDA208258
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: TAZAROTENE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 22 December 2017
- Application: ANDA208662
- Marketing authorisation holder: COSETTE
- Local brand name: TAZAROTENE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 28 January 2019
- Application: ANDA211175
- Marketing authorisation holder: FOUGERA PHARMS INC
- Local brand name: TAZAROTENE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 13 September 2022
- Application: ANDA215433
- Marketing authorisation holder: COSETTE
- Local brand name: TAZAROTENE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 13 September 2022
- Application: ANDA214136
- Marketing authorisation holder: COSETTE
- Local brand name: TAZAROTENE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 20 March 2023
- Application: ANDA213644
- Marketing authorisation holder: SOLARIS PHARMA CORP
- Local brand name: TAZAROTENE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 25 April 2023
- Application: ANDA213079
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: TAZAROTENE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 15 July 2024
- Application: ANDA217075
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: TAZAROTENE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 29 July 2025
- Application: ANDA215393
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: TAZAROTENE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 24 November 2025
- Application: ANDA214560
- Marketing authorisation holder: SOLARIS PHARMA CORP
- Local brand name: TAZAROTENE
- Indication: CREAM — TOPICAL
- Status: approved
Other Dermatology approved in United States
Frequently asked questions
Is Tazarotene Cream 0.05% approved in United States?
Yes. FDA authorised it on 29 September 2000; FDA authorised it on 3 April 2017; FDA authorised it on 22 December 2017.
Who is the marketing authorisation holder for Tazarotene Cream 0.05% in United States?
ALMIRALL holds the US marketing authorisation.