FDA — authorised 15 October 1956
- Status: approved
🇺🇸 Fluotestin in United States
FDA authorised Fluotestin on 15 October 1956
Marketing authorisations
FDA — authorised 15 October 1956
- Application: NDA010611
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: HALOTESTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 July 1981
- Application: ANDA087196
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: ANDROID-F
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 May 1983
- Application: ANDA088221
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: FLUOXYMESTERONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 October 1983
- Application: ANDA088342
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: FLUOXYMESTERONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088265
- Marketing authorisation holder: WATSON LABS
- Local brand name: FLUOXYMESTERONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088309
- Marketing authorisation holder: WATSON LABS
- Local brand name: FLUOXYMESTERONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA011359
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: ORA-TESTRYL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088260
- Marketing authorisation holder: WATSON LABS
- Local brand name: FLUOXYMESTERONE
- Indication: TABLET — ORAL
- Status: approved
Fluotestin 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 Fluotestin approved in United States?
Yes. FDA authorised it on 15 October 1956; FDA authorised it on 15 October 1956; FDA authorised it on 6 July 1981.
Who is the marketing authorisation holder for Fluotestin in United States?
Marketing authorisation holder not available in our data.