FDA Orange Book · active-ingredient family
Anastrozole
Anastrozole: 1 brand, 19 generics; first approved Dec 27, 1995; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 19 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
19
Listed patents
0
Presentations
20
Brand (NDA) products
Originator applications
- ANI PHARMSNDA 0205411995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB
Generic (ANDA) products (19)
Abbreviated applications
- ANASTROZOLEEUGIA PHARMAANDA 2124342020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB - ANASTROZOLEBEIJING YILINGANDA 2060372018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB - ANASTROZOLEIMPAX LABS INCANDA 0912422012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - ANASTROZOLEAPOTEX INCANDA 2006542012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - ANASTROZOLESUN PHARM INDS LTDANDA 0911772011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - ANASTROZOLECHARTWELL MOLECULARANDA 0913312011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - ANASTROZOLEACCORD HLTHCAREANDA 0905682010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB - ANASTROZOLECHARTWELL RXANDA 0907322010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - ANASTROZOLECIPLAANDA 0911642010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB - ANASTROZOLEFRESENIUS KABI USAANDA 0900882010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - ANASTROZOLEHIKMAANDA 0784852010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - ANASTROZOLEKENTONANDA 0789442010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB - ANASTROZOLENATCO PHARMA LTDANDA 0792202010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB - ANASTROZOLEPHARMOBEDIENTANDA 0910512010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - ANASTROZOLESANDOZANDA 0790072010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - ANASTROZOLESYNTHON PHARMSANDA 0783222010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - ANASTROZOLETEVA PHARMSANDA 0780582010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB - ANASTROZOLEWATSON LABS TEVAANDA 0789842010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - ANASTROZOLEZYDUS PHARMS USA INCANDA 0789212010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB
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
31 yr 1 mo ago
Most recent approval
6 yr 2 mo ago
Approvals span 1995–2020 across 20 FDA applications.
Brand (NDA) 15%
Generic (ANDA) 1995%
Anastrozole: 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.
