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FDA Orange Book · active-ingredient family

Anastrozole

Anastrozole is approved as 1 brand and 19 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ARIMIDEX · NDA 020541

1

Brand (NDA)

19

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
ARIMIDEXRLDANI PHARMSNDA 020541ABDec 27, 1995

Generic (ANDA) products (19)

ProductApplicantApplicationTEApproved
ANASTROZOLEEUGIA PHARMAANDA 212434ABJul 24, 2020
ANASTROZOLEBEIJING YILINGANDA 206037ABNov 09, 2018
ANASTROZOLEIMPAX LABS INCANDA 091242—May 31, 2012
ANASTROZOLEAPOTEX INCANDA 200654—May 11, 2012
ANASTROZOLESUN PHARM INDS LTDANDA 091177—Jul 15, 2011
ANASTROZOLECHARTWELL MOLECULARANDA 091331—Jan 05, 2011
ANASTROZOLEACCORD HLTHCAREANDA 090568ABJun 28, 2010
ANASTROZOLECHARTWELL RXANDA 090732—Jun 28, 2010
ANASTROZOLECIPLAANDA 091164ABJun 28, 2010
ANASTROZOLEFRESENIUS KABI USAANDA 090088—Jun 28, 2010
ANASTROZOLEHIKMAANDA 078485—Jun 28, 2010
ANASTROZOLEKENTONANDA 078944ABJun 28, 2010
ANASTROZOLENATCO PHARMA LTDANDA 079220ABJun 28, 2010
ANASTROZOLEPHARMOBEDIENTANDA 091051—Jun 28, 2010
ANASTROZOLESANDOZANDA 079007—Jun 28, 2010
ANASTROZOLESYNTHON PHARMSANDA 078322—Jun 28, 2010
ANASTROZOLETEVA PHARMSANDA 078058ABJun 28, 2010
ANASTROZOLEWATSON LABS TEVAANDA 078984—Jun 28, 2010
ANASTROZOLEZYDUS PHARMS USA INCANDA 078921ABJun 28, 2010

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.

Anastrozole — frequently asked questions

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

Agent CTA Background

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