Paroxetine Hydrochloride

Sold as Paxil, Paxil Cr. Every FDA application for this active ingredient: 4 branded and 27 generic.

As of Nov 15, 2026, FDA lists 31 applications for Paroxetine Hydrochloride (sold as Paxil, Paxil Cr), first approved Dec 29, 1992, with 9 new uses approved and 0 published complete response letters.

First approved: Dec 29, 1992
Applications: 31
New uses approved: 9
Complete response letters: 0
Medicare spending, 2025: $57.6M

Medicare Spending

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


Paroxetine HCl	Part D	$46.2M	+1%	671,532
Paroxetine ER	Part D	$4.5M	-8%	14,260
Paroxetine Cr	Part D	$3.1M	-4%	11,175
Paxil Cr	Part D	$2.1M	+1%	544
Paxil	Part D	$1.6M	-4%	578

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

PAROXETINE ER 12.5 MG TABLET: $0.482 per unitGeneric · -5% in a year
PAROXETINE ER 25 MG TABLET: $0.398 per unitGeneric · -21% in a year
PAROXETINE ER 37.5 MG TABLET: $0.439 per unitGeneric · -18% in a year
PAROXETINE HCL 10 MG TABLET: $0.063 per unitGeneric · -10% in a year
PAROXETINE HCL 10 MG/5 ML SUSP: $1.40 per MLGeneric · +4% in a year
PAROXETINE HCL 20 MG TABLET: $0.063 per unitGeneric · -12% in a year
PAROXETINE HCL 30 MG TABLET: $0.099 per unitGeneric · +3% in a year
PAROXETINE HCL 40 MG TABLET: $0.098 per unitGeneric · -10% in a year
PAROXETINE MESYLATE 7.5 MG CAP: $2.64 per unitGeneric · +4% in a year
PAXIL 20 MG TABLET: $10.74 per unitBrand · new this year
PAXIL 30 MG TABLET: $10.81 per unitBrand · new this year
PAXIL 40 MG TABLET: $11.50 per unitBrand · new this year

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

PaxilDrugs with a new additional indication and a new dosage for the treatment of posttraumatic stress disorder. · GlaxoSmithKline K.K. · Nov 22, 2013
PaxilDrugs with a new additional indication and a new dosage for the treatment of social anxiety disorder. · GlaxoSmithKline K.K. · Oct 16, 2009

Clinical Trials

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


Biomarkers and Pharmacogenomics for Precision Depression TherapyDepression / Major Depressive Disorder · The Fourth Affiliated Hospital of Zhejiang University School of Medicine	Not applicable	Not yet recruiting	Jul 31, 2026
Estimation of Control Before and After Treatment of a Depressive Episode With Serotonin Reuptake InhibitorsDepression Disorder · Hôpital le Vinatier	Not applicable	Not yet recruiting	Jul 21, 2026
Antidepressant Therapy for Improved Blood Vessel Health After PreeclampsiaPreeclampsia, Endothelial Function · Anna Stanhewicz, PhD	Early phase 1	Recruiting	Jul 20, 2026
A Phase I Study of NS-079 in Healthy ParticipantsHealthy Adult Participants · NeuShen Therapeutics	Phase 1	Recruiting	Jun 25, 2026
Electroacupuncture for Generalized Anxiety Disorder: Clinical Efficacy and Neuroimaging MechanismsGeneralized Anxiety Disorder · Lishu Gao	Not applicable	Recruiting	Feb 6, 2026
Neurobiological and Genomic Predictors of Relapse in DepressionHealthy, Major Depressive Disorder (MDD) · Mehmet Kemal Arikan	—	Recruiting	Jan 9, 2026
Building Ukraine's Strength in PTSD Treatment and ResearchPost Traumatic Stress Disorder, Post Traumatic Stress Disorder PTSD · University of Luxembourg	Not applicable	Recruiting	Jan 5, 2026
Efficacy of Chronotherapeutic Combination for Major Depressive Episode With InsomniaMajor Depressive Disorder (MDD) With Insomnia · Assistance Publique - Hôpitaux de Paris	Phase 3	Recruiting	Aug 13, 2025

Applications

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


Dec 29, 1992	PaxilNDA 20031 · New molecular entity	Apotex	64	Marketed
Jun 25, 1997	PaxilNDA 20710 · New dosage form	Apotex	34	Discontinued
Oct 9, 1998	PaxilNDA 20885 · New dosage form	Apotex	4	Discontinued
Feb 16, 1999	Paxil CrNDA 20936 · New dosage form	Apotex	42	Marketed
Jul 30, 2003	Paroxetine HydrochlorideANDA 75356	Apotex	17	Marketed
Mar 8, 2004	Paroxetine HydrochlorideANDA 75566	Upsher Smith Labs	3	Discontinued
Mar 8, 2004	Paroxetine HydrochlorideANDA 75716	Pharmobedient	9	Discontinued
Aug 15, 2005	Paroxetine HydrochlorideANDA 76618	Chartwell Rx	16	Marketed
Dec 4, 2006	Paroxetine HydrochlorideANDA 77395	Apotex Inc	14	Discontinued
Mar 7, 2007	Paroxetine HydrochlorideANDA 77584	Zydus Pharms USA	19	Marketed
Jun 29, 2007	Paroxetine HydrochlorideANDA 77082	Teva Pharms	1	Discontinued
Jun 29, 2007	Paroxetine HydrochlorideANDA 78026	Roxane	0	Discontinued
Jun 29, 2007	Paroxetine HydrochlorideANDA 78194	Sun Pharm Inds Inc	6	Discontinued
Jun 29, 2007	Paroxetine HydrochlorideANDA 77873	Aurobindo Pharma USA	14	Marketed
Jul 25, 2007	Paroxetine HydrochlorideANDA 78406	Aurobindo Pharma	15	Marketed
Mar 13, 2008	Paroxetine HydrochlorideANDA 78902	Mylan	11	Marketed
Jun 21, 2010	Paroxetine HydrochlorideANDA 76968	Oxford Pharms	2	Marketed
Apr 14, 2011	Paroxetine HydrochlorideANDA 91427	Aurobindo Pharma USA	8	Marketed
Oct 31, 2014	ParoxetineANDA 203854	Prinston	3	Marketed
Nov 27, 2015	Paroxetine HydrochlorideANDA 205528	Jubilant Generics	0	Discontinued
Jun 10, 2016	Paroxetine HydrochlorideANDA 204744	Lannett Co Inc	0	Marketed
Jan 20, 2017	Paroxetine HydrochlorideANDA 204134	Lupin	0	Discontinued
Jun 12, 2018	Paroxetine HydrochlorideANDA 209293	Sciecure Pharma Inc	0	Marketed
Feb 16, 2021	Paroxetine HydrochlorideANDA 213485	Cspc Ouyi	1	Marketed
Aug 11, 2021	Paroxetine HydrochlorideANDA 213612	Epic Pharma LLC	1	Discontinued
Aug 27, 2021	Paroxetine HydrochlorideANDA 212645	Cadila Pharms Ltd	3	Marketed
Sep 3, 2021	Paroxetine HydrochlorideANDA 215003	Novitium Pharma	2	Marketed
Nov 2, 2021	Paroxetine HydrochlorideANDA 211248	Pharmobedient	0	Marketed
Jan 4, 2024	Paroxetine HydrochlorideANDA 209748	Prinston	0	Marketed
Sep 24, 2025	Paroxetine HydrochlorideANDA 217280	Alembic	1	Marketed
Mar 5, 2026	Paroxetine HydrochlorideANDA 219954	Annora Pharma	0	Marketed

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