FDA — authorised 18 October 1979
- Application: NDA018116
- Marketing authorisation holder: ASTELLAS
- Local brand name: CYCLOCORT
- Indication: CREAM — TOPICAL
- Status: approved
🇺🇸 Cyclocort in United States
FDA authorised Cyclocort on 18 October 1979
Marketing authorisations
FDA — authorised 13 November 1981
- Application: NDA018498
- Marketing authorisation holder: ASTELLAS
- Local brand name: CYCLOCORT
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 13 June 1988
- Application: NDA019729
- Marketing authorisation holder: ASTELLAS
- Local brand name: CYCLOCORT
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 31 May 2002
- Application: ANDA076229
- Marketing authorisation holder: TARO PHARM INDS
- Local brand name: AMCINONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 6 November 2002
- Application: ANDA076329
- Marketing authorisation holder: SOLUBIOMIX
- Local brand name: AMCINONIDE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 19 November 2002
- Application: ANDA076096
- Marketing authorisation holder: GENUS
- Local brand name: AMCINONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 19 March 2003
- Application: ANDA076367
- Marketing authorisation holder: TARO PHARM INDS
- Local brand name: AMCINONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 15 May 2003
- Application: ANDA076065
- Marketing authorisation holder: GENUS LIFESCIENCES
- Local brand name: AMCINONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Status: approved
Cyclocort 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 Cyclocort approved in United States?
Yes. FDA authorised it on 18 October 1979; FDA authorised it on 13 November 1981; FDA authorised it on 13 June 1988.
Who is the marketing authorisation holder for Cyclocort in United States?
ASTELLAS holds the US marketing authorisation.