FDA — authorised 18 September 2001
- Application: ANDA075298
- Marketing authorisation holder: WAYLIS THERAP
- Local brand name: FLUTAMIDE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 AA in United States
FDA authorised AA on 18 September 2001
Marketing authorisations
FDA — authorised 18 September 2001
- Application: ANDA075818
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: FLUTAMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 September 2001
- Application: ANDA075820
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: FLUTAMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 September 2001
- Application: ANDA075780
- Marketing authorisation holder: CIPLA
- Local brand name: FLUTAMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 May 2003
- Application: ANDA076224
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: FLUTAMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 July 2009
- Application: ANDA078917
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: BICALUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 July 2009
- Application: ANDA076932
- Marketing authorisation holder: TEVA
- Local brand name: BICALUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 July 2009
- Application: ANDA079185
- Marketing authorisation holder: RISING
- Local brand name: BICALUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 July 2009
- Application: ANDA077973
- Marketing authorisation holder: SYNTHON PHARMS
- Local brand name: BICALUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 July 2009
- Application: ANDA078575
- Marketing authorisation holder: SANDOZ
- Local brand name: BICALUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 July 2009
- Application: ANDA077995
- Marketing authorisation holder: KUDCO IRELAND
- Local brand name: BICALUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 August 2009
- Application: ANDA078634
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: BICALUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 May 2010
- Application: ANDA079045
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: BICALUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 March 2011
- Application: ANDA078285
- Marketing authorisation holder: ROXANE
- Local brand name: BICALUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 May 2015
- Application: ANDA200274
- Marketing authorisation holder: APOTEX
- Local brand name: BICALUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 June 2015
- Application: ANDA091011
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: BICALUTAMIDE
- Indication: TABLET — ORAL
- Status: approved
Other Oncology approved in United States
Frequently asked questions
Is AA approved in United States?
Yes. FDA authorised it on 18 September 2001; FDA authorised it on 18 September 2001; FDA authorised it on 18 September 2001.
Who is the marketing authorisation holder for AA in United States?
WAYLIS THERAP holds the US marketing authorisation.