Orange Book product · Brand (NDA)
HALOTESTIN
FLUOXYMESTERONE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
FLUOXYMESTERONE
Strength
2MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 010611
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- —ORA-TESTRYLBrand (NDA)
NDA 011359 · BRISTOL MYERS SQUIBB
- 1983FLUOXYMESTERONEGeneric (ANDA)
ANDA 088260 · WATSON LABS
- 1983FLUOXYMESTERONEGeneric (ANDA)
ANDA 088265 · WATSON LABS
- 1983FLUOXYMESTERONEGeneric (ANDA)
ANDA 088309 · WATSON LABS
- 1983FLUOXYMESTERONEGeneric (ANDA)
ANDA 088342 · UPSHER SMITH LABS
- 1983FLUOXYMESTERONEGeneric (ANDA)
ANDA 088221 · VALEANT PHARM INTL
- —ANDROID-FGeneric (ANDA)
ANDA 087196 · VALEANT PHARM INTL
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
