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FDA Orange Book · active-ingredient family

Fluoxetine hydrochloride

Fluoxetine hydrochloride is approved as 6 brand and 69 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:FLUOXETINE HYDROCHLORIDE · NDA 202133

6

Brand (NDA)

69

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, capsule, delayed rel pellets, solution, tablet

ProductApplicantApplicationTEApproved
FLUOXETINE HYDROCHLORIDERLDTWI PHARMSNDA 202133—Oct 06, 2011
SARAFEMRLD×3APILNDA 021860—May 19, 2006
PROZAC WEEKLYRLDLILLYNDA 021235—Feb 26, 2001
PROZACRLD×2LILLYNDA 020974—Mar 09, 1999
PROZACRLD×6ELI LILLY AND CONDA 018936—Dec 23, 1992
PROZACRLDLILLYNDA 020101—Apr 24, 1991

Generic (ANDA) products (69)

ProductApplicantApplicationTEApproved
FLUOXETINE HYDROCHLORIDESTRIDES PHARMAANDA 212683ABSep 13, 2024
FLUOXETINE HYDROCHLORIDE×2STRIDES PHARMAANDA 212684ABApr 05, 2024
FLUOXETINE HYDROCHLORIDEUPSHER SMITH LABSANDA 216953AANov 15, 2022
FLUOXETINE HYDROCHLORIDENOVITIUM PHARMAANDA 216448AANov 09, 2022
FLUOXETINE HYDROCHLORIDE×2CHARTWELL RXANDA 211444—Sep 13, 2022
FLUOXETINE HYDROCHLORIDE×3MICRO LABSANDA 216232AB1Mar 29, 2022
FLUOXETINE HYDROCHLORIDE×3ACCORD HLTHCAREANDA 202729—Aug 27, 2020
FLUOXETINE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 213265ABJun 10, 2020
FLUOXETINE HYDROCHLORIDE×2AUROBINDO PHARMA LTDANDA 213286ABApr 08, 2020
FLUOXETINE HYDROCHLORIDEG AND W LABS INCANDA 212191—Jul 05, 2019
FLUOXETINE HYDROCHLORIDE×3CADILA PHARMS LTDANDA 206993AB1May 23, 2019
FLUOXETINE HYDROCHLORIDE×2LUPINANDA 211653ABApr 15, 2019
FLUOXETINE HYDROCHLORIDE×2SCIEGEN PHARMSANDA 210935ABMar 20, 2019
FLUOXETINE HYDROCHLORIDELUPINANDA 211632—Feb 08, 2019
FLUOXETINE HYDROCHLORIDE×2SOMERSET THERAPS LLCANDA 211696—Jan 30, 2019
FLUOXETINE HYDROCHLORIDEDR REDDYSANDA 211721ABJan 25, 2019
FLUOXETINE HYDROCHLORIDESCIEGEN PHARMSANDA 211282ABJan 10, 2019
FLUOXETINE HYDROCHLORIDETEVA PHARMS USAANDA 211051—Dec 03, 2018
FLUOXETINE HYDROCHLORIDESOMERSET THERAPS LLCANDA 211477ABNov 21, 2018
FLUOXETINE HYDROCHLORIDEINVENTIA HLTHCAREANDA 209695ABNov 20, 2017
FLUOXETINE HYDROCHLORIDEPH HEALTHANDA 209419ABNov 16, 2017
FLUOXETINE HYDROCHLORIDE×2ALEMBICANDA 208698ABApr 05, 2017
FLUOXETINE HYDROCHLORIDE×2TORRENTANDA 206937—Oct 21, 2016
FLUOXETINE HYDROCHLORIDE×2PH HEALTHANDA 203836ABAug 19, 2016
FLUOXETINE HYDROCHLORIDE×3SCIEGEN PHARMSANDA 204597AB1Mar 16, 2015
SELFEMRA×3TEVA PHARMS USAANDA 200151—Feb 03, 2014
FLUOXETINE HYDROCHLORIDE×3HERITAGEANDA 201336AB1Oct 01, 2012
FLUOXETINE HYDROCHLORIDEBARRANDA 076237—Mar 24, 2010
FLUOXETINE HYDROCHLORIDEDR REDDYS LABS LTDANDA 078572—Mar 22, 2010
FLUOXETINE HYDROCHLORIDEAUROBINDO PHARMAANDA 079209AAMar 20, 2009
FLUOXETINE HYDROCHLORIDE×3ALEMBIC PHARMS LTDANDA 090223AB1Mar 19, 2009
FLUOXETINE HYDROCHLORIDE×2NATCO PHARMA USAANDA 078045—Nov 17, 2008
FLUOXETINE HYDROCHLORIDE×2SANDOZANDA 077469—Nov 17, 2008
FLUOXETINE HYDROCHLORIDE×2ANI PHARMSANDA 076287—May 20, 2008
FLUOXETINE HYDROCHLORIDE×3AUROBINDO PHARMAANDA 078619AB1Jan 31, 2008
FLUOXETINE HYDROCHLORIDE×3CHARTWELL RXANDA 078143—Jan 16, 2008
FLUOXETINE HYDROCHLORIDELANNETT CO INCANDA 077849AAFeb 09, 2007
FLUOXETINE HYDROCHLORIDEBARRANDA 076251—May 18, 2005
FLUOXETINE HYDROCHLORIDE×3STRIDES PHARMA INTLANDA 076922—Dec 16, 2004
FLUOXETINE HYDROCHLORIDESUN PHARM INDS LTDANDA 076990—Dec 13, 2004
FLUOXETINE HYDROCHLORIDECHARTWELL MOLECULARANDA 076458—May 14, 2004
FLUOXETINE HYDROCHLORIDEPHARMOBEDIENT CNSLTGANDA 075514—Aug 29, 2002
FLUOXETINE HYDROCHLORIDESCIEGEN PHARMSANDA 075525AAJun 27, 2002
FLUOXETINE HYDROCHLORIDE×2IVAX SUB TEVA PHARMSANDA 075865—Feb 28, 2002
FLUOXETINE HYDROCHLORIDESOLIS PHARMSANDA 075292AAFeb 07, 2002
FLUOXETINE HYDROCHLORIDE×2CR DOUBLE CRANEANDA 076165—Feb 01, 2002
FLUOXETINE HYDROCHLORIDEBARRANDA 075810—Feb 01, 2002
FLUOXETINE HYDROCHLORIDE×3IVAX SUB TEVA PHARMSANDA 075245AB1Jan 31, 2002
FLUOXETINE HYDROCHLORIDEACTAVIS MID ATLANTICANDA 075690—Jan 31, 2002
FLUOXETINE HYDROCHLORIDE×2BARRANDA 074803—Jan 30, 2002
FLUOXETINE HYDROCHLORIDE×2CARLSBADANDA 076022—Jan 30, 2002
FLUOXETINE HYDROCHLORIDE×2LANDELA PHARMANDA 075464AB1Jan 30, 2002
FLUOXETINE HYDROCHLORIDE×3PHARMOBEDIENTANDA 075207—Jan 30, 2002
FLUOXETINE HYDROCHLORIDEPHARM ASSOCANDA 076015—Jan 30, 2002
FLUOXETINE HYDROCHLORIDE×2DR REDDYSANDA 076006ABJan 30, 2002
FLUOXETINE×2SUN PHARM INDUSTRIESANDA 075787—Jan 29, 2002
FLUOXETINE×2WATSON LABSANDA 075662—Jan 29, 2002
FLUOXETINE HYDROCHLORIDE×3MARKSANS PHARMAANDA 075465AB1Jan 29, 2002
FLUOXETINE HYDROCHLORIDE×2PHARMOBEDIENTANDA 075577—Jan 29, 2002
FLUOXETINE HYDROCHLORIDE×2REGCON HOLDINGSANDA 075807—Jan 29, 2002
FLUOXETINE HYDROCHLORIDE×2SPECGX LLCANDA 075658—Jan 29, 2002
FLUOXETINE HYDROCHLORIDE×3TEVAANDA 075452AB1Jan 29, 2002
FLUOXETINE HYDROCHLORIDE×2TEVA PHARMS USAANDA 076001AB1Jan 29, 2002
FLUOXETINE HYDROCHLORIDEBAJAJANDA 075920—Jan 29, 2002
FLUOXETINE HYDROCHLORIDEFOSUN PHARMAANDA 076024—Jan 29, 2002
FLUOXETINE HYDROCHLORIDE×2TEVAANDA 075872—Jan 29, 2002
FLUOXETINE HYDROCHLORIDE×3SENORES PHARMSANDA 075049AB1Aug 02, 2001
FLUOXETINE HYDROCHLORIDETEVAANDA 075506AAAug 02, 2001
FLUOXETINE HYDROCHLORIDE×2RISINGANDA 075755—Aug 02, 2001

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.

Fluoxetine hydrochloride — 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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