Fluoxetine Hydrochloride

Treats Major Depressive Disorder. Sold as Prozac, Sarafem, Prozac Weekly, Fluoxetine Hydrochloride. Every FDA application for this active ingredient: 6 branded and 69 generic.

As of Nov 15, 2026, FDA lists 75 applications for Fluoxetine Hydrochloride (sold as Prozac, Sarafem, Prozac Weekly and others), first approved Dec 29, 1987, with 12 new uses approved and 0 published complete response letters.

First approved: Dec 29, 1987
Applications: 75
New uses approved: 12
Complete response letters: 0
Medicare spending, 2025: $96.9M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Fluoxetine HCl	Part D	$87.0M	+6%	1,522,719
Prozac	Part D	$8.8M	-44%	1,892
Fluoxetine Dr	Part D	$1.2M	-8%	1,066

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

FLUOXETINE 20 MG/5 ML SOLUTION: $0.217 per MLGeneric · +2% in a year
FLUOXETINE DR 90 MG CAPSULE: $30.55 per unitGeneric · +1% in a year
FLUOXETINE HCL 10 MG CAPSULE: $0.034 per unitGeneric · +3% in a year
FLUOXETINE HCL 10 MG TABLET: $0.065 per unitGeneric · -30% in a year
FLUOXETINE HCL 20 MG CAPSULE: $0.029 per unitGeneric · +0% in a year
FLUOXETINE HCL 20 MG TABLET: $0.097 per unitGeneric · +0% in a year
FLUOXETINE HCL 40 MG CAPSULE: $0.054 per unitGeneric · -16% in a year
FLUOXETINE HCL 60 MG TABLET: $0.185 per unitGeneric · -45% in a year

Orphan Designations (FDA)

2 designations, 0 approved for the designated use; see all orphan designations

Treatment of body dysmorphic disorder in children and adolescentsHollander, Eric MD · designated Apr 14, 2004
Treatment of autism.Neuropharm, Ltd. · designated Apr 30, 1999

Clinical Trials

8 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Neurobiological and Genomic Predictors of Relapse in DepressionHealthy, Major Depressive Disorder (MDD) · Mehmet Kemal Arikan	—	Recruiting	Jan 9, 2026
Disposition Kinetics of Dolutegravir Among People Living With HIV With Major Depression in NigeriaDepression, HIV · University of Ibadan	Phase 4	Not yet recruiting	Aug 8, 2025
Clinical Effect and Mechanism Study of Five Elements Music Therapy(FEMT) on Depression DisorderDepression Disorder, Depression Disorders · Shanghai Mental Health Center	Not applicable	Not yet recruiting	Jul 3, 2025
Effect of Exercise on Tapering Antipsychotics in Patients With Psycho-cardiological Disease(EXTRA-study)Cardiovascular Diseases (CVD), Depression Anxiety Disorder · Guangdong Provincial People's Hospital	Not applicable	Recruiting	Jun 17, 2025
Identifying and Treating Depression in the Orthopaedic Trauma PopulationDepression · Wake Forest University Health Sciences	Phase 4	Recruiting	Aug 4, 2023
Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)Depression, Sequestra · First Affiliated Hospital of Chongqing Medical University	Phase 1 / Phase 2	Recruiting	Apr 18, 2023
Efficacy of Hydroxyzine for Patients With Panic DisorderPanic Disorder · Sultan Qaboos University	Phase 4	Not yet recruiting	Feb 21, 2023
National Pregnancy Registry for Psychiatric MedicationsPregnant Women, Psychotropic Drugs · Massachusetts General Hospital	—	Recruiting	Nov 23, 2010

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 29, 1987	Prozac, SarafemNDA 18936 · New molecular entity	Eli Lilly And Co	88	Discontinued
Apr 24, 1991	ProzacNDA 20101 · New dosage form	Lilly	30	Discontinued
Mar 9, 1999	ProzacNDA 20974 · New dosage form	Lilly	8	Discontinued
Feb 26, 2001	Prozac WeeklyNDA 21235 · New dosage form	Lilly	21	Discontinued
Aug 2, 2001	Fluoxetine HydrochlorideANDA 74803	Barr	18	Discontinued
Aug 2, 2001	Fluoxetine HydrochlorideANDA 75049	Pharmazone	26	Marketed
Aug 2, 2001	Fluoxetine HydrochlorideANDA 75506	Teva	19	Marketed
Aug 2, 2001	Fluoxetine HydrochlorideANDA 75755	Rising	15	Discontinued
Jan 29, 2002	FluoxetineANDA 75662	Watson Labs	2	Discontinued
Jan 29, 2002	Fluoxetine HydrochlorideANDA 75920	Bajaj	17	Discontinued
Jan 29, 2002	Fluoxetine HydrochlorideANDA 76001	Teva Pharms USA	29	Marketed
Jan 29, 2002	Fluoxetine HydrochlorideANDA 76024	Fosun Pharma	6	Discontinued
Jan 29, 2002	FluoxetineANDA 75787	Sun Pharm Industries	3	Discontinued
Jan 29, 2002	Fluoxetine HydrochlorideANDA 75452	Teva	23	Marketed
Jan 29, 2002	Fluoxetine HydrochlorideANDA 75465	Pharmazone	13	Marketed
Jan 29, 2002	Fluoxetine HydrochlorideANDA 75577	Pharmobedient	10	Discontinued
Jan 29, 2002	Fluoxetine HydrochlorideANDA 75658	Specgx LLC	23	Discontinued
Jan 29, 2002	Fluoxetine HydrochlorideANDA 75807	Regcon Holdings	5	Discontinued
Jan 29, 2002	Fluoxetine HydrochlorideANDA 75872	Teva	22	Discontinued
Jan 30, 2002	Fluoxetine HydrochlorideANDA 75464	Landela Pharm	2	Marketed
Jan 30, 2002	Fluoxetine HydrochlorideANDA 76006	Dr Reddys	9	Marketed
Jan 30, 2002	Fluoxetine HydrochlorideANDA 76022	Carlsbad	2	Discontinued
Jan 30, 2002	Fluoxetine HydrochlorideANDA 75207	Pharmobedient	16	Discontinued
Jan 30, 2002	Fluoxetine HydrochlorideANDA 76015	Pharm Assoc	14	Discontinued
Jan 31, 2002	Fluoxetine HydrochlorideANDA 75690	Actavis Mid Atlantic	3	Discontinued
Jan 31, 2002	Fluoxetine HydrochlorideANDA 75245	Ivax Sub Teva Pharms	18	Marketed
Feb 1, 2002	Fluoxetine HydrochlorideANDA 75810	Barr	3	Discontinued
Feb 1, 2002	Fluoxetine HydrochlorideANDA 76165	Cr Double Crane	3	Discontinued
Feb 7, 2002	Fluoxetine HydrochlorideANDA 75292	Solis Pharms	16	Marketed
Feb 28, 2002	Fluoxetine HydrochlorideANDA 75865	Ivax Sub Teva Pharms	3	Discontinued
Jun 27, 2002	Fluoxetine HydrochlorideANDA 75525	Sciegen Pharms	6	Marketed
Aug 29, 2002	Fluoxetine HydrochlorideANDA 75514	Pharmobedient Cnsltg	14	Discontinued
May 14, 2004	Fluoxetine HydrochlorideANDA 76458	Chartwell Molecular	11	Discontinued
Dec 13, 2004	Fluoxetine HydrochlorideANDA 76990	Sun Pharm Inds Ltd	21	Discontinued
Dec 16, 2004	Fluoxetine HydrochlorideANDA 76922	Strides Pharma Intl	11	Discontinued
May 18, 2005	Fluoxetine HydrochlorideANDA 76251	Barr	0	Discontinued
May 19, 2006	SarafemNDA 21860 · New dosage form	Apil	10	Discontinued
Feb 9, 2007	Fluoxetine HydrochlorideANDA 77849	Lannett Co Inc	12	Marketed
Jan 16, 2008	Fluoxetine HydrochlorideANDA 78143	Chartwell Rx	4	Discontinued
Jan 31, 2008	Fluoxetine HydrochlorideANDA 78619	Aurobindo Pharma	18	Marketed
May 20, 2008	Fluoxetine HydrochlorideANDA 76287	Ani Pharms	8	Discontinued
Nov 17, 2008	Fluoxetine HydrochlorideANDA 78045	Natco Pharma USA	7	Discontinued
Nov 17, 2008	Fluoxetine HydrochlorideANDA 77469	Sandoz	8	Discontinued
Mar 19, 2009	Fluoxetine HydrochlorideANDA 79209	Aurobindo Pharma	11	Marketed
Mar 19, 2009	Fluoxetine HydrochlorideANDA 90223	Alembic Pharms Ltd	9	Marketed
Mar 22, 2010	Fluoxetine HydrochlorideANDA 78572	Dr Reddys Labs Ltd	10	Marketed
Mar 24, 2010	Fluoxetine HydrochlorideANDA 76237	Barr	5	Discontinued
Oct 6, 2011	Fluoxetine HydrochlorideNDA 202133 · New dosage form	Twi Pharms	6	Discontinued
Oct 1, 2012	Fluoxetine HydrochlorideANDA 201336	Heritage	5	Marketed
Feb 3, 2014	SelfemraANDA 200151	Teva Pharms USA	7	Discontinued
Mar 16, 2015	Fluoxetine HydrochlorideANDA 204597	Sciegen Pharms	6	Marketed
Aug 19, 2016	Fluoxetine HydrochlorideANDA 203836	Ph Health	2	Marketed
Oct 21, 2016	Fluoxetine HydrochlorideANDA 206937	Torrent	4	Marketed
Apr 5, 2017	Fluoxetine HydrochlorideANDA 208698	Alembic	2	Marketed
Nov 16, 2017	Fluoxetine HydrochlorideANDA 209419	Ph Health	2	Marketed
Nov 20, 2017	Fluoxetine HydrochlorideANDA 209695	Adaptis	2	Marketed
Nov 21, 2018	Fluoxetine HydrochlorideANDA 211477	Somerset Theraps LLC	2	Marketed
Dec 3, 2018	Fluoxetine HydrochlorideANDA 211051	Teva Pharms USA	0	Discontinued
Jan 10, 2019	Fluoxetine HydrochlorideANDA 211282	Sciegen Pharms	2	Marketed
Jan 25, 2019	Fluoxetine HydrochlorideANDA 211721	Dr Reddys	2	Marketed
Jan 30, 2019	Fluoxetine HydrochlorideANDA 211696	Somerset Theraps LLC	2	Discontinued
Feb 8, 2019	Fluoxetine HydrochlorideANDA 211632	Lupin	2	Discontinued
Mar 20, 2019	Fluoxetine HydrochlorideANDA 210935	Sciegen Pharms	3	Marketed
Apr 15, 2019	Fluoxetine HydrochlorideANDA 211653	Lupin	2	Marketed
May 23, 2019	Fluoxetine HydrochlorideANDA 206993	Cadila Pharms Ltd	3	Marketed
Jul 5, 2019	Fluoxetine HydrochlorideANDA 212191	G And W Labs Inc	0	Discontinued
Apr 8, 2020	Fluoxetine HydrochlorideANDA 213286	Aurobindo Pharma Ltd	3	Marketed
Jun 10, 2020	Fluoxetine HydrochlorideANDA 213265	Aurobindo Pharma Ltd	3	Marketed
Aug 27, 2020	Fluoxetine HydrochlorideANDA 202729	Accord Hlthcare	1	Discontinued
Mar 29, 2022	Fluoxetine HydrochlorideANDA 216232	Micro Labs	1	Discontinued
Sep 13, 2022	Fluoxetine HydrochlorideANDA 211444	Chartwell Rx	1	Discontinued
Nov 9, 2022	Fluoxetine HydrochlorideANDA 216448	Novitium Pharma	1	Marketed
Nov 15, 2022	Fluoxetine HydrochlorideANDA 216953	Upsher Smith Labs	1	Marketed
Apr 5, 2024	Fluoxetine HydrochlorideANDA 212684	Strides Pharma	0	Marketed
Sep 13, 2024	Fluoxetine HydrochlorideANDA 212683	Strides Pharma	0	Marketed

Show all 75

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA