FDA Orange Book · active-ingredient family
Fluoxetine hydrochloride
Fluoxetine hydrochloride: 6 brands, 69 generics; first approved Dec 29, 1987; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 69 ANDA applications approved.
Brands (NDA)
6
Generics (ANDA)
69
Listed patents
0
Presentations
139
Brand (NDA) products
Originator applications
- FLUOXETINE HYDROCHLORIDERLDTWI PHARMSNDA 2021332011
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 60MG BASE TABLET ORAL Discontinued - - SARAFEMRLDAPILNDA 02186020063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued - EQ 15MG BASE TABLET ORAL Discontinued - EQ 20MG BASE TABLET ORAL Discontinued - - LILLYNDA 0212352001
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 90MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued - - PROZACRLDLILLYNDA 02097419992 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued - EQ 20MG BASE TABLET ORAL Discontinued - - PROZACRLDELI LILLY AND CONDA 01893619926 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE ORAL Discontinued - EQ 40MG BASE CAPSULE ORAL Discontinued - EQ 60MG BASE CAPSULE ORAL Discontinued - EQ 10MG BASE CAPSULE ORAL Discontinued - EQ 10MG BASE CAPSULE ORAL Discontinued - EQ 20MG BASE CAPSULE ORAL Discontinued - - PROZACRLDLILLYNDA 0201011991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/5ML SOLUTION ORAL Discontinued -
Generic (ANDA) products (69)
Abbreviated applications
- FLUOXETINE HYDROCHLORIDESTRIDES PHARMAANDA 2126832024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 60MG BASE TABLET ORAL Rx AB - FLUOXETINE HYDROCHLORIDESTRIDES PHARMAANDA 21268420242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB - FLUOXETINE HYDROCHLORIDEUPSHER SMITH LABSANDA 2169532022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/5ML SOLUTION ORAL Rx AA - FLUOXETINE HYDROCHLORIDENOVITIUM PHARMAANDA 2164482022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/5ML SOLUTION ORAL Rx AA - FLUOXETINE HYDROCHLORIDECHARTWELL RXANDA 21144420222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued - EQ 20MG BASE TABLET ORAL Discontinued - - FLUOXETINE HYDROCHLORIDEMICRO LABSANDA 21623220223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Discontinued - EQ 20MG BASE CAPSULE ORAL Discontinued - EQ 40MG BASE CAPSULE ORAL Discontinued - - FLUOXETINE HYDROCHLORIDEACCORD HLTHCAREANDA 20272920203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Discontinued - EQ 20MG BASE CAPSULE ORAL Discontinued - EQ 40MG BASE CAPSULE ORAL Discontinued - - FLUOXETINE HYDROCHLORIDERSAUROBINDO PHARMA LTDANDA 2132652020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 60MG BASE TABLET ORAL Rx AB - FLUOXETINE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 21328620202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB - FLUOXETINE HYDROCHLORIDEG AND W LABS INCANDA 2121912019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 60MG BASE TABLET ORAL Discontinued - - FLUOXETINE HYDROCHLORIDECADILA PHARMS LTDANDA 20699320193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Rx AB1 EQ 20MG BASE CAPSULE ORAL Rx AB1 EQ 40MG BASE CAPSULE ORAL Rx AB - FLUOXETINE HYDROCHLORIDELUPINANDA 21165320192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB - FLUOXETINE HYDROCHLORIDESCIEGEN PHARMSANDA 21093520192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB - FLUOXETINE HYDROCHLORIDELUPINANDA 2116322019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 60MG BASE TABLET ORAL Discontinued - - FLUOXETINE HYDROCHLORIDESOMERSET THERAPS LLCANDA 21169620192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued - EQ 20MG BASE TABLET ORAL Discontinued - - FLUOXETINE HYDROCHLORIDEDR REDDYSANDA 2117212019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 60MG BASE TABLET ORAL Rx AB - FLUOXETINE HYDROCHLORIDESCIEGEN PHARMSANDA 2112822019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 60MG BASE TABLET ORAL Rx AB - FLUOXETINE HYDROCHLORIDETEVA PHARMS USAANDA 2110512018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 60MG BASE TABLET ORAL Discontinued - - FLUOXETINE HYDROCHLORIDESOMERSET THERAPS LLCANDA 2114772018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 60MG BASE TABLET ORAL Rx AB - FLUOXETINE HYDROCHLORIDEINVENTIA HLTHCAREANDA 2096952017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 60MG BASE TABLET ORAL Rx AB - FLUOXETINE HYDROCHLORIDEPH HEALTHANDA 2094192017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 60MG BASE TABLET ORAL Rx AB - FLUOXETINE HYDROCHLORIDEALEMBICANDA 20869820172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB - FLUOXETINE HYDROCHLORIDETORRENTANDA 20693720162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx - EQ 20MG BASE TABLET ORAL Rx - - FLUOXETINE HYDROCHLORIDEPH HEALTHANDA 20383620162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB - FLUOXETINE HYDROCHLORIDESCIEGEN PHARMSANDA 20459720153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Rx AB1 EQ 20MG BASE CAPSULE ORAL Rx AB1 EQ 40MG BASE CAPSULE ORAL Rx AB - TEVA PHARMS USAANDA 20015120143 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued - EQ 15MG BASE TABLET ORAL Discontinued - EQ 20MG BASE TABLET ORAL Discontinued - - FLUOXETINE HYDROCHLORIDEHERITAGEANDA 20133620123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Rx AB1 EQ 20MG BASE CAPSULE ORAL Rx AB1 EQ 40MG BASE CAPSULE ORAL Rx AB - FLUOXETINE HYDROCHLORIDEBARRANDA 0762372010
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 90MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued - - FLUOXETINE HYDROCHLORIDERSDR REDDYS LABS LTDANDA 0785722010
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 90MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx - - FLUOXETINE HYDROCHLORIDERSAUROBINDO PHARMAANDA 0792092009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/5ML SOLUTION ORAL Rx AA - FLUOXETINE HYDROCHLORIDEALEMBIC PHARMS LTDANDA 09022320093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Rx AB1 EQ 20MG BASE CAPSULE ORAL Rx AB1 EQ 40MG BASE CAPSULE ORAL Rx AB - FLUOXETINE HYDROCHLORIDENATCO PHARMA USAANDA 07804520082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Discontinued - EQ 20MG BASE CAPSULE ORAL Discontinued - - FLUOXETINE HYDROCHLORIDESANDOZANDA 07746920082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Discontinued - EQ 20MG BASE CAPSULE ORAL Discontinued - - FLUOXETINE HYDROCHLORIDEANI PHARMSANDA 07628720082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Discontinued - EQ 20MG BASE CAPSULE ORAL Discontinued - - FLUOXETINE HYDROCHLORIDEAUROBINDO PHARMAANDA 07861920083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Rx AB1 EQ 20MG BASE CAPSULE ORAL Rx AB1 EQ 40MG BASE CAPSULE ORAL Rx AB - FLUOXETINE HYDROCHLORIDECHARTWELL RXANDA 07814320083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Discontinued - EQ 20MG BASE CAPSULE ORAL Discontinued - EQ 40MG BASE CAPSULE ORAL Discontinued - - FLUOXETINE HYDROCHLORIDELANNETT CO INCANDA 0778492007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/5ML SOLUTION ORAL Rx AA - FLUOXETINE HYDROCHLORIDEBARRANDA 0762512005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE CAPSULE ORAL Discontinued - - FLUOXETINE HYDROCHLORIDESTRIDES PHARMA INTLANDA 07692220043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Discontinued - EQ 20MG BASE CAPSULE ORAL Discontinued - EQ 40MG BASE CAPSULE ORAL Discontinued - - FLUOXETINE HYDROCHLORIDESUN PHARM INDS LTDANDA 0769902004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE CAPSULE ORAL Discontinued - - FLUOXETINE HYDROCHLORIDECHARTWELL MOLECULARANDA 0764582004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/5ML SOLUTION ORAL Discontinued - - FLUOXETINE HYDROCHLORIDEPHARMOBEDIENT CNSLTGANDA 0755142002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/5ML SOLUTION ORAL Discontinued - - FLUOXETINE HYDROCHLORIDESCIEGEN PHARMSANDA 0755252002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/5ML SOLUTION ORAL Rx AA - FLUOXETINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 07586520022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued - EQ 40MG BASE TABLET ORAL Discontinued - - FLUOXETINE HYDROCHLORIDESOLIS PHARMSANDA 0752922002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/5ML SOLUTION ORAL Rx AA - FLUOXETINE HYDROCHLORIDECR DOUBLE CRANEANDA 07616520022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Discontinued - EQ 20MG BASE CAPSULE ORAL Discontinued - - FLUOXETINE HYDROCHLORIDEBARRANDA 0758102002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued - - FLUOXETINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 07524520023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE ORAL Rx AB1 EQ 10MG BASE CAPSULE ORAL Rx AB1 EQ 40MG BASE CAPSULE ORAL Rx AB - FLUOXETINE HYDROCHLORIDEACTAVIS MID ATLANTICANDA 0756902002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/5ML SOLUTION ORAL Discontinued - - FLUOXETINE HYDROCHLORIDEBARRANDA 07480320022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE ORAL Discontinued - EQ 10MG BASE CAPSULE ORAL Discontinued - - FLUOXETINE HYDROCHLORIDECARLSBADANDA 07602220022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Discontinued - EQ 20MG BASE CAPSULE ORAL Discontinued - - FLUOXETINE HYDROCHLORIDELANDELA PHARMANDA 07546420022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Rx AB1 EQ 20MG BASE CAPSULE ORAL Rx AB1 - FLUOXETINE HYDROCHLORIDEPHARMOBEDIENTANDA 07520720023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Discontinued - EQ 20MG BASE CAPSULE ORAL Discontinued - EQ 40MG BASE CAPSULE ORAL Discontinued - - FLUOXETINE HYDROCHLORIDEPHARM ASSOCANDA 0760152002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/5ML SOLUTION ORAL Discontinued - - FLUOXETINE HYDROCHLORIDEDR REDDYSANDA 07600620022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Rx AB EQ 20MG BASE TABLET ORAL Rx AB - SUN PHARM INDUSTRIESANDA 07578720022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Discontinued - EQ 20MG BASE CAPSULE ORAL Discontinued - - WATSON LABSANDA 07566220022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Discontinued - EQ 20MG BASE CAPSULE ORAL Discontinued - - FLUOXETINE HYDROCHLORIDEMARKSANS PHARMAANDA 07546520023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Rx AB1 EQ 20MG BASE CAPSULE ORAL Rx AB1 EQ 40MG BASE CAPSULE ORAL Rx AB - FLUOXETINE HYDROCHLORIDEPHARMOBEDIENTANDA 07557720022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Discontinued - EQ 20MG BASE CAPSULE ORAL Discontinued - - FLUOXETINE HYDROCHLORIDEREGCON HOLDINGSANDA 07580720022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Discontinued - EQ 20MG BASE CAPSULE ORAL Discontinued - - FLUOXETINE HYDROCHLORIDESPECGX LLCANDA 07565820022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Discontinued - EQ 20MG BASE CAPSULE ORAL Discontinued - - FLUOXETINE HYDROCHLORIDETEVAANDA 07545220023 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Rx AB1 EQ 20MG BASE CAPSULE ORAL Rx AB1 EQ 40MG BASE CAPSULE ORAL Rx AB - FLUOXETINE HYDROCHLORIDETEVA PHARMS USAANDA 07600120022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Rx AB1 EQ 20MG BASE CAPSULE ORAL Rx AB1 - FLUOXETINE HYDROCHLORIDEBAJAJANDA 0759202002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/5ML SOLUTION ORAL Discontinued - - FLUOXETINE HYDROCHLORIDEFOSUN PHARMAANDA 0760242002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued - - FLUOXETINE HYDROCHLORIDETEVAANDA 07587220022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued - EQ 20MG BASE TABLET ORAL Discontinued - - FLUOXETINE HYDROCHLORIDESENORES PHARMSANDA 07504920013 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE CAPSULE ORAL Rx AB1 EQ 20MG BASE CAPSULE ORAL Rx AB1 EQ 40MG BASE CAPSULE ORAL Rx AB - FLUOXETINE HYDROCHLORIDETEVAANDA 0755062001
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/5ML SOLUTION ORAL Rx AA - FLUOXETINE HYDROCHLORIDERISINGANDA 07575520012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE TABLET ORAL Discontinued - EQ 20MG BASE TABLET 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
39 yr 5 mo ago
Most recent approval
2 yr 2 mo ago
Approvals span 1987–2024 across 75 FDA applications.
Brand (NDA) 68%
Generic (ANDA) 6992%
Fluoxetine 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.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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