Fluoxymesterone
Fluoxymesterone: 2 brands, 6 generics; first approved May 05, 1983; generic available.
Generic available: 6 ANDA applications approved.
Brand (NDA) products
- 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 - - 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 -
Generic (ANDA) products (6)
- FLUOXYMESTERONEWATSON LABSANDA 0882601983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued - - FLUOXYMESTERONEWATSON LABSANDA 0882651983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - - FLUOXYMESTERONEWATSON LABSANDA 0883091983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - FLUOXYMESTERONEUPSHER SMITH LABSANDA 0883421983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - FLUOXYMESTERONEVALEANT PHARM INTLANDA 0882211983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - VALEANT PHARM INTLANDA 087196-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued -
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.
Approval history
All 8 applications were approved in 1983.
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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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