FDA — authorised 14 December 1990
- Application: NDA019957
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: CUTIVATE
- Indication: OINTMENT — TOPICAL
- Status: approved
🇺🇸 Cutivate in United States
FDA authorised Cutivate on 14 December 1990
Marketing authorisations
FDA — authorised 14 December 1990
- Marketing authorisation holder: FOUGERA PHARMS
- Status: approved
FDA — authorised 18 December 1990
- Application: NDA019958
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: CUTIVATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 14 May 2004
- Application: ANDA076633
- Marketing authorisation holder: ENCUBE
- Status: approved
FDA — authorised 31 March 2005
- Application: NDA021152
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: CUTIVATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 3 March 2006
- Application: ANDA077168
- Marketing authorisation holder: COSETTE
- Status: approved
FDA — authorised 7 January 2019
- Application: NDA021254
- Marketing authorisation holder: GLAXO GRP LTD
- Indication: Labeling
- Status: approved
FDA — authorised 15 August 2025
- Application: ANDA219060
- Marketing authorisation holder: RUBICON
- Status: approved
FDA — authorised 3 March 2026
- Application: ANDA219602
- Marketing authorisation holder: GLENMARK SPECLT
- Status: approved
Cutivate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Cutivate approved in United States?
Yes. FDA authorised it on 14 December 1990; FDA authorised it on 14 December 1990; FDA authorised it on 18 December 1990.
Who is the marketing authorisation holder for Cutivate in United States?
FOUGERA PHARMS holds the US marketing authorisation.