Regulatory PathRegulatory requirements compared

Active substance

Paroxetine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
AXOR 20 mg film-coated tablet20 mgFilm-coated tablet · Oral use30 BlisterSAR 48.85Generic · PrescriptionEVA PHARMAValid
AXOR 30 mg film-coated tablet30 mgFilm-coated tablet · Oral use30 BlisterSAR 60.10Generic · PrescriptionEVA PHARMAValid
AXOR 40 mg film-coated tablet40 mgFilm-coated tablet · Oral use30 BlisterSAR 80.15Generic · PrescriptionEVA PHARMAValid
PADO 20MG FILM COATED TABLET20 mgFilm-coated tablet · Oral use30 BlisterSAR 31.40Generic · PrescriptionUNITED PHARMACEUTICAL CO.Valid
PAROXAT 10 MG F-C TABLETS10 mgFilm-coated tablet · Oral use30 BlisterSAR 30.15Generic · PrescriptionSPIMACO ADDWAEIHValid
PAROXAT 20 MG F-C TABLETS20 mgFilm-coated tablet · Oral use30 BlisterSAR 60.30Generic · PrescriptionSPIMACO ADDWAEIHValid
PAROXAT 30MG F-C TABLETS30 mgFilm-coated tablet · Oral use30 BlisterSAR 78.25Generic · PrescriptionSPIMACO ADDWAEIHValid
PAXITAB 20MG TABLET20 mgTablet · Oral use30 BlisterSAR 54.30Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
PAXITAB 40MG TABLET40 mgTablet · Oral use30 BlisterSAR 89.05Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
Parlotin20 mgFilm-coated tablet · Oral use30 BlisterSAR 15.20Generic · PrescriptionBLUEPHARMA GENERICOS,COMERCIO DE MEDICAMENTOS , S.A.Valid
SEROXAT 20MG TABLETS20 mgTablet · Oral use30 BlisterSAR 60.30NCE · PrescriptionGLAXO SAUDI ARABIAValid
SEROXAT CR 12.5MG TABLETS12.5 mgTablet · Oral use30 BlisterSAR 61.90NCE · PrescriptionGlaxo Saudi Arabia Ltd.Valid
SEROXAT CR 25MG TABLETS25 mgTablet · Oral use30 BlisterSAR 82.30NCE · PrescriptionGlaxo Saudi Arabia Ltd.Valid
SEROXAT CR 12.5 MG TABLETS12.5 mgTablet · Oral use30 BlisterSAR 93.85NCE · PrescriptionSMIITHKLINE BEECHAMWithdrawn by MAH · Not Marketed
SEROXAT CR 25 MG TABLETS25 mgTablet · Oral use30 BlisterSAR 159.05NCE · PrescriptionSMIITHKLINE BEECHAMWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ABDOMINAL SPASM; ACUTE BIPOLAR I DEPRESSION; ALZHEIMER / DEMENTIA; ANXIETY DISORDERS; ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD); DEPRESSION; FIBROMYALGIA; HUNTINGTON'S DISEASE-TICS; IRRITABLE BOWEL SYNDROME; MENOPAUSE; MENSTRUAL DISORDERS; NEUROPATHIC PAIN; PAIN MANAGEMENT IN CANCER PATIENTS; POLYCYTHEMIA VERA - PRURITUS

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
PAXILEQ 10MG BASE; EQ 20MG BASE; EQ 30MG BASE; EQ 40MG BASEtablet · oralAPOTEXPrescription29 Dec 1992
PAXIL CREQ 12.5MG BASE; EQ 25MG BASE; EQ 37.5MG BASEtablet, extended release · oralAPOTEXPrescription16 Feb 1999
PAROXETINE HYDROCHLORIDEEQ 10MG BASE; EQ 20MG BASE; EQ 30MG BASE; EQ 40MG BASEtablet · oralAPOTEXPrescription30 Jul 2003
PAROXETINE HYDROCHLORIDEEQ 10MG BASE; EQ 20MG BASE; EQ 30MG BASE; EQ 40MG BASEtablet · oralCHARTWELL RXPrescription15 Aug 2005
PAROXETINE HYDROCHLORIDEEQ 10MG BASE; EQ 20MG BASE; EQ 30MG BASE; EQ 40MG BASEtablet · oralZYDUS PHARMS USAPrescription7 Mar 2007
PAROXETINE HYDROCHLORIDEEQ 12.5MG BASE; EQ 25MG BASEtablet, extended release · oralAUROBINDO PHARMA USAPrescription29 Jun 2007
PAROXETINE HYDROCHLORIDEEQ 10MG BASE; EQ 20MG BASE; EQ 30MG BASE; EQ 40MG BASEtablet · oralAUROBINDO PHARMAPrescription25 Jul 2007
PAROXETINE HYDROCHLORIDEEQ 10MG BASE; EQ 20MG BASE; EQ 30MG BASE; EQ 40MG BASEtablet · oralMYLANPrescription13 Mar 2008
PAROXETINE HYDROCHLORIDEEQ 10MG BASE; EQ 20MG BASE; EQ 30MG BASE; EQ 40MG BASEtablet · oralOXFORD PHARMSPrescription21 Jun 2010
PAROXETINE HYDROCHLORIDEEQ 37.5MG BASEtablet, extended release · oralAUROBINDO PHARMA USAPrescription14 Apr 2011
BRISDELLEEQ 7.5MG BASEcapsule · oralLEGACYPrescription28 Jun 2013
PAROXETINEEQ 10MG BASE; EQ 20MG BASE; EQ 30MG BASE; EQ 40MG BASEtablet · oralPRINSTON INCPrescription31 Oct 2014
PAROXETINE HYDROCHLORIDEEQ 12.5MG BASE; EQ 25MG BASE; EQ 37.5MG BASEtablet, extended release · oralLANNETT CO INCPrescription10 Jun 2016
PAROXETINE MESYLATEEQ 7.5MG BASEcapsule · oralACTAVIS LABS FL INCPrescription20 Jun 2017
PAROXETINE MESYLATEEQ 7.5MG BASEcapsule · oralPRINSTON INCPrescription18 Aug 2017
PAROXETINE HYDROCHLORIDEEQ 12.5MG BASE; EQ 25MG BASE; EQ 37.5MG BASEtablet, extended release · oralSCIECURE PHARMA INCPrescription12 Jun 2018
PAROXETINE HYDROCHLORIDEEQ 12.5MG BASE; EQ 25MG BASE; EQ 37.5MG BASEtablet, extended release · oralCSPC OUYIPrescription16 Feb 2021
PAROXETINE HYDROCHLORIDEEQ 12.5MG BASE; EQ 25MG BASE; EQ 37.5MG BASEtablet, extended release · oralCADILA PHARMS LTDPrescription27 Aug 2021
PAROXETINE HYDROCHLORIDEEQ 10MG BASE/5MLsuspension · oralNOVITIUM PHARMAPrescription3 Sep 2021
PAROXETINE HYDROCHLORIDEEQ 10MG BASE; EQ 20MG BASE; EQ 30MG BASE; EQ 40MG BASEtablet · oralYILINGPrescription2 Nov 2021
PAROXETINE HYDROCHLORIDEEQ 12.5MG BASE; EQ 25MG BASEtablet, extended release · oralPRINSTON INCPrescription4 Jan 2024
PAROXETINE HYDROCHLORIDEEQ 25MG BASE; EQ 37.5MG BASE; EQ 12.5MG BASEtablet, extended release · oralALEMBICPrescription24 Sep 2025
PAROXETINE HYDROCHLORIDEEQ 10MG BASE/5MLsuspension · oralANNORA PHARMAPrescription5 Mar 2026
PAXILEQ 50MG BASEtablet · oralAPOTEXDiscontinued29 Dec 1992
PAXILEQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**suspension · oralAPOTEXDiscontinued25 Jun 1997

11 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AG-PAROXETINE TABLETS0251048010 MGTABLET · ORALANGITA PHARMA INC.
AG-PAROXETINE TABLETS0251049920 MGTABLET · ORALANGITA PHARMA INC.
AG-PAROXETINE TABLETS0251051030 MGTABLET · ORALANGITA PHARMA INC.
APO-PAROXETINE0224090710 MGTABLET · ORALAPOTEX INC
APO-PAROXETINE0224090820 MGTABLET · ORALAPOTEX INC
APO-PAROXETINE0224090930 MGTABLET · ORALAPOTEX INC
AURO-PAROXETINE0238327610 MGTABLET · ORALAURO PHARMA INC
AURO-PAROXETINE0238328420 MGTABLET · ORALAURO PHARMA INC
AURO-PAROXETINE0238329230 MGTABLET · ORALAURO PHARMA INC
BIO-PAROXETINE0244490910 MGTABLET · ORALBIOMED PHARMA
BIO-PAROXETINE0244491720 MGTABLET · ORALBIOMED PHARMA
BIO-PAROXETINE0244492530 MGTABLET · ORALBIOMED PHARMA
JAMP PAROXETINE TABLETS0250777310 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP PAROXETINE TABLETS0250778120 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP PAROXETINE TABLETS0250780330 MGTABLET · ORALJAMP PHARMA CORPORATION
M-PAROXETINE0246740210 MGTABLET · ORALMANTRA PHARMA INC
M-PAROXETINE0246741020 MGTABLET · ORALMANTRA PHARMA INC
M-PAROXETINE0246742930 MGTABLET · ORALMANTRA PHARMA INC
MAR-PAROXETINE0241194610 MGTABLET · ORALMARCAN PHARMACEUTICALS INC
MAR-PAROXETINE0241195420 MGTABLET · ORALMARCAN PHARMACEUTICALS INC
MAR-PAROXETINE0241196230 MGTABLET · ORALMARCAN PHARMACEUTICALS INC
MINT-PAROXETINE0242137210 MGTABLET · ORALMINT PHARMACEUTICALS INC
MINT-PAROXETINE0242138020 MGTABLET · ORALMINT PHARMACEUTICALS INC
MINT-PAROXETINE0242139930 MGTABLET · ORALMINT PHARMACEUTICALS INC
NRA-PAROXETINE0247975310 MGTABLET · ORALNORA PHARMA INC

26 more — full table

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACPAROXETINE CR 12.5 MG TABLET$0.52008per EA23 Sep 2026
US NADACPAROXETINE CR 25 MG TABLET$0.38562per EA23 Sep 2026
US NADACPAROXETINE CR 37.5 MG TABLET$0.3974per EA23 Sep 2026
US NADACPAROXETINE ER 12.5 MG TABLET$0.52008per EA23 Sep 2026
US NADACPAROXETINE ER 25 MG TABLET$0.38562per EA23 Sep 2026
US NADACPAROXETINE ER 37.5 MG TABLET$0.3974per EA23 Sep 2026
US NADACPAROXETINE HCL 10 MG TABLET$0.06189per EA23 Sep 2026
US NADACPAROXETINE HCL 10 MG/5 ML SUSP$1.40007per ML23 Sep 2026
US NADACPAROXETINE HCL 20 MG TABLET$0.06108per EA23 Sep 2026
US NADACPAROXETINE HCL 30 MG TABLET$0.09543per EA23 Sep 2026
US NADACPAROXETINE HCL 40 MG TABLET$0.09655per EA23 Sep 2026
US NADACPAROXETINE MESYLATE 7.5 MG CAP$2.62233per EA23 Sep 2026
NHS Drug TariffParoxetine 10mg tablets£1.0228 tablet1 Oct 2026
NHS Drug TariffParoxetine 20mg tablets£1.2130 tablet1 Oct 2026
NHS Drug TariffParoxetine 30mg tablets£1.4530 tablet1 Oct 2026
NHS Drug TariffParoxetine 40mg tablets£6.4030 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

  • 24.3. Medicines for anxiety disorders · core (EML); complementary (EMLc)
    Therapeutic equivalent to fluoxetine for Generalised anxiety disorder

Safety signals and safety-related labeling changes

All safety entries for paroxetine →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.