FDA — authorised 27 December 1985
- Marketing authorisation holder: FOUGERA PHARMS
- Status: approved
🇺🇸 Temovate in United States
FDA authorised Temovate on 27 December 1985
Marketing authorisations
FDA — authorised 27 December 1985
- Application: NDA019322
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: TEMOVATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 22 February 1990
- Application: NDA019966
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: TEMOVATE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 29 April 1994
- Application: NDA020337
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: TEMOVATE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 12 August 1998
- Application: ANDA075057
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Status: approved
FDA — authorised 10 March 2008
- Application: ANDA077763
- Marketing authorisation holder: PADAGIS ISRAEL
- Status: approved
FDA — authorised 30 November 2012
- Application: NDA021644
- Marketing authorisation holder: GALDERMA LABS
- Indication: Labeling
- Status: approved
FDA — authorised 10 May 2018
- Application: ANDA209095
- Marketing authorisation holder: GLENMARK SPECLT
- Status: approved
FDA — authorised 29 November 2023
- Application: ANDA210809
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Indication: Labeling
- Status: approved
Temovate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Temovate approved in United States?
Yes. FDA authorised it on 27 December 1985; FDA authorised it on 27 December 1985; FDA authorised it on 22 February 1990.
Who is the marketing authorisation holder for Temovate in United States?
FOUGERA PHARMS holds the US marketing authorisation.