FDA Orange Book · active-ingredient family
Finasteride
Finasteride: 2 brands, 22 generics; first approved Jun 19, 1992; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 22 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
22
Listed patents
0
Presentations
24
Brand (NDA) products
Originator applications
Generic (ANDA) products (22)
Abbreviated applications
- FINASTERIDEALKEM LABS LTDANDA 2077502017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB - FINASTERIDEALKEM LABS LTDANDA 2043042017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - FINASTERIDECIPLAANDA 0773352014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FINASTERIDEACCORD HLTHCAREANDA 0916432013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB - FINASTERIDEACTAVIS TOTOWAANDA 0783712013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FINASTERIDEAUROBINDO PHARMA LTDANDA 2036872013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB - FINASTERIDENATCO PHARMAANDA 0781612013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FINASTERIDETEVAANDA 0769052013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - FINASTERIDEHETERO LABS LTD IIIANDA 0900602013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB - FINASTERIDESUN PHARMANDA 0905082013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB - FINASTERIDESUN PHARMANDA 0905072011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - FINASTERIDEHETERO LABS LTD IIIANDA 0900612010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - FINASTERIDEACCORD HLTHCAREANDA 0901212010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - FINASTERIDEZYDUS PHARMS USA INCANDA 0789002009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - FINASTERIDEAUROBINDO PHARMAANDA 0783412007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - FINASTERIDEACTAVIS TOTOWA TEVAANDA 0779142007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - FINASTERIDEDR REDDYS LABS LTDANDA 0764372007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - FINASTERIDEGEDEON RICHTER USAANDA 0772512006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - FINASTERIDEMYLANANDA 0775782006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — - FINASTERIDETEVAANDA 0765112006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB - FINASTERIDEDR REDDYS LABS INCANDA 0764362006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB - FINASTERIDEIVAX SUB TEVA PHARMSANDA 0763402006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
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
FDA approval span
First approval
34 yr 8 mo ago
Most recent approval
9 yr 9 mo ago
Approvals span 1992–2017 across 24 FDA applications.
Brand (NDA) 28%
Generic (ANDA) 2292%
Finasteride: 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.
