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: 2 brands, 6 generics; first approved May 05, 1983; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 6 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

HALOTESTIN

PHARMACIA AND UPJOHNNDA 010611—3 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—
10MG	TABLET	ORAL	Discontinued	—

ORA-TESTRYL

BRISTOL MYERS SQUIBBNDA 011359—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Discontinued	—
5MG	TABLET	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (6)

FLUOXYMESTERONE

WATSON LABSANDA 0882601983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Discontinued	—

FLUOXYMESTERONE

WATSON LABSANDA 0882651983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	—

FLUOXYMESTERONE

WATSON LABSANDA 0883091983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—

FLUOXYMESTERONE

UPSHER SMITH LABSANDA 0883421983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—

FLUOXYMESTERONE

VALEANT PHARM INTLANDA 0882211983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—

ANDROID-F

VALEANT PHARM INTLANDA 087196—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TABLET	ORAL	Discontinued	—

Orange Book patent file

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.

FDA approval span

Approval history

First approval

May 05, 1983

43 yr 10 mo ago

Most recent approval

Dec 06, 1983

43 yr 3 mo ago

All 8 applications were approved in 1983.

Brand (NDA) 225%

Generic (ANDA) 675%

Fluoxymesterone — frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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