Is there a generic for Fluoxymesterone?

Yes. The FDA Orange Book lists 6 approved generic (ANDA) applications for Fluoxymesterone, referencing the brand HALOTESTIN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Fluoxymesterone?

HALOTESTIN (NDA 010611, PHARMACIA AND UPJOHN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Fluoxymesterone are approved?

Fluoxymesterone is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Fluoxymesterone

Fluoxymesterone is approved as 2 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:HALOTESTIN · NDA 010611

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
HALOTESTIN×3	PHARMACIA AND UPJOHN	NDA 010611	—	Approved Prior to Jan 1, 1982
ORA-TESTRYL×2	BRISTOL MYERS SQUIBB	NDA 011359	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (6)

Product	Applicant	Application	TE	Approved
FLUOXYMESTERONE	WATSON LABS	ANDA 088260	—	Dec 06, 1983
FLUOXYMESTERONE	WATSON LABS	ANDA 088265	—	Dec 06, 1983
FLUOXYMESTERONE	WATSON LABS	ANDA 088309	—	Dec 06, 1983
FLUOXYMESTERONE	UPSHER SMITH LABS	ANDA 088342	—	Oct 21, 1983
FLUOXYMESTERONE	VALEANT PHARM INTL	ANDA 088221	—	May 05, 1983
ANDROID-F	VALEANT PHARM INTL	ANDA 087196	—	Approved Prior to Jan 1, 1982

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.

Fluoxymesterone — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo