FDA — authorised 3 December 1957
- Application: NDA011161
- Marketing authorisation holder: ASTELLAS
- Local brand name: ARISTOCORT
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Rodinolone in United States
FDA authorised Rodinolone on 3 December 1957
Marketing authorisations
FDA — authorised 3 December 1957
- Status: approved
FDA — authorised 16 October 1975
- Application: ANDA084268
- Marketing authorisation holder: BARR
- Local brand name: TRIAMCINOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 1975
- Application: ANDA084267
- Marketing authorisation holder: BARR
- Local brand name: TRIAMCINOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 February 1977
- Application: ANDA084270
- Marketing authorisation holder: WATSON LABS
- Local brand name: TRIAMCINOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 March 1978
- Application: ANDA085692
- Marketing authorisation holder: FOUGERA PHARMS
- Status: approved
FDA — authorised 30 July 1982
- Application: ANDA085601
- Marketing authorisation holder: SANDOZ
- Local brand name: TRIAMCINOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 May 1983
- Application: ANDA085691
- Marketing authorisation holder: FOUGERA PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 19 March 1984
- Application: ANDA088042
- Marketing authorisation holder: CROWN LABS
- Status: approved
FDA — authorised 5 October 2018
- Application: ANDA209852
- Marketing authorisation holder: TEVA PHARMS USA
- Status: approved
FDA — authorised 18 August 2023
- Application: ANDA216625
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Status: approved
FDA
- Application: ANDA084709
- Marketing authorisation holder: ROXANE
- Local brand name: TRIAMCINOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084707
- Marketing authorisation holder: ROXANE
- Local brand name: TRIAMCINOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084708
- Marketing authorisation holder: ROXANE
- Local brand name: TRIAMCINOLONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084020
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: TRIAMCINOLONE
- Indication: TABLET — ORAL
- Status: approved
Rodinolone 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 Rodinolone approved in United States?
Yes. FDA authorised it on 3 December 1957; FDA authorised it on 3 December 1957; FDA authorised it on 16 October 1975.
Who is the marketing authorisation holder for Rodinolone in United States?
ASTELLAS holds the US marketing authorisation.