FDA Orange Book · active-ingredient family
Alfuzosin hydrochloride
Alfuzosin hydrochloride: 1 brand, 9 generics; first approved Jun 12, 2003; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 9 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
9
Listed patents
0
Presentations
10
Brand (NDA) products
Originator applications
- ADVANZ PHARMANDA 0212872003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, EXTENDED RELEASE ORAL Rx AB
Generic (ANDA) products (9)
Abbreviated applications
- ALFUZOSIN HYDROCHLORIDEUNICHEMANDA 2031922016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, EXTENDED RELEASE ORAL Rx AB - ALFUZOSIN HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 0790602012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, EXTENDED RELEASE ORAL Rx AB - ALFUZOSIN HYDROCHLORIDEWOCKHARDT BIO AGANDA 0902212012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ALFUZOSIN HYDROCHLORIDEINVAGEN PHARMSANDA 0902842012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, EXTENDED RELEASE ORAL Rx AB - ALFUZOSIN HYDROCHLORIDEAPOTEX INCANDA 0790132011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, EXTENDED RELEASE ORAL Rx AB - ALFUZOSIN HYDROCHLORIDECHARTWELL RXANDA 0790562011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ALFUZOSIN HYDROCHLORIDEPHARMOBEDIENTANDA 0790142011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ALFUZOSIN HYDROCHLORIDESUN PHARMANDA 0790572011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ALFUZOSIN HYDROCHLORIDETORRENT PHARMSANDA 0790542011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, EXTENDED RELEASE 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
23 yr 6 mo ago
Most recent approval
10 yr 9 mo ago
Approvals span 2003–2016 across 10 FDA applications.
Brand (NDA) 110%
Generic (ANDA) 990%
Alfuzosin hydrochloride: 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.
