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FDA Orange Book · active-ingredient family

Letrozole

Letrozole is approved as 1 brand and 20 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:FEMARA · NDA 020726

1

Brand (NDA)

20

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
FEMARARLDNOVARTIS PHARMSNDA 020726ABJul 25, 1997

Generic (ANDA) products (20)

ProductApplicantApplicationTEApproved
LETROZOLEEUGIA PHARMAANDA 211717ABJan 11, 2019
LETROZOLEBEIJING YILINGANDA 205869ABNov 14, 2018
LETROZOLEHIKMA PHARMSANDA 203796—Jun 03, 2016
LETROZOLELANNETT CO INCANDA 202048—Oct 29, 2014
LETROZOLECHARTWELL RXANDA 202716—May 16, 2013
LETROZOLEAPOTEX INCANDA 091303—Apr 19, 2012
LETROZOLEACTAVIS TOTOWAANDA 090292—Jul 13, 2011
LETROZOLEACCORD HLTHCAREANDA 090934ABJun 03, 2011
LETROZOLECARNEGIEANDA 091191—Jun 03, 2011
LETROZOLEFRESENIUS KABI USAANDA 090491—Jun 03, 2011
LETROZOLEHIKMAANDA 090838—Jun 03, 2011
LETROZOLEIMPAX LABSANDA 091638—Jun 03, 2011
LETROZOLEINDICUS PHARMAANDA 201804—Jun 03, 2011
LETROZOLELANNETT CO INCANDA 091098—Jun 03, 2011
LETROZOLENATCO PHARMA LTDANDA 200161ABJun 03, 2011
LETROZOLESTRIDES PHARMA INTLANDA 090789—Jun 03, 2011
LETROZOLESUN PHARM INDS LTDANDA 091466—Jun 03, 2011
LETROZOLESYNTHON PHARMSANDA 090196—Jun 03, 2011
LETROZOLETEVA PHARMSANDA 090289ABJun 03, 2011
LETROZOLEPHARMOBEDIENTANDA 078190—Dec 24, 2008

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.

Letrozole — 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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