Regulatory PathRegulatory requirements compared

Active substance

Atomoxetine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Acumen10 mgCapsule, hard · Oral use28 BlisterSAR 160.75Generic · PrescriptionALTAIF PHARMACEUTICALS COMPANYValid
Acumen18 mgCapsule, hard · Oral use28 BlisterSAR 160.75Generic · PrescriptionALTAIF PHARMACEUTICALS COMPANYValid
Acumen25 mgCapsule, hard · Oral use28 BlisterSAR 160.75Generic · PrescriptionALTAIF PHARMACEUTICALS COMPANYValid
Acumen40 mgCapsule, hard · Oral use28 BlisterSAR 160.75Generic · PrescriptionALTAIF PHARMACEUTICALS COMPANYValid
Acumen60 mgCapsule, hard · Oral use28 BlisterSAR 160.75Generic · PrescriptionALTAIF PHARMACEUTICALS COMPANYValid
Attencare10 mgCapsule, hard · Oral use30 BlisterSAR 190.85Generic · PrescriptionApex PharmaValid
Attencare18 mgCapsule, hard · Oral use30 BlisterSAR 190.85Generic · PrescriptionApex PharmaValid
Attencare25 mgCapsule, hard · Oral use30 BlisterSAR 190.85Generic · PrescriptionApex PharmaValid
Attencare40 mgCapsule, hard · Oral use30 BlisterSAR 190.85Generic · PrescriptionApex PharmaValid
Attencare60 mgCapsule, hard · Oral use30 BlisterSAR 190.85Generic · PrescriptionApex PharmaValid
Axepta10 mgCapsule, hard · Oral use30 BlisterSAR 181.30Generic · PrescriptionMS Pharma Saudi (MSPS)Valid
Axepta18 mgCapsule, hard · Oral use30 BlisterSAR 181.30Generic · PrescriptionMS Pharma Saudi (MSPS)Valid
Axepta25 mgCapsule, hard · Oral use30 BlisterSAR 181.30Generic · PrescriptionMS Pharma Saudi (MSPS)Valid
Axepta40 mgCapsule, hard · Oral use30 BlisterSAR 181.30Generic · PrescriptionMS Pharma Saudi (MSPS)Valid
Axepta60 mgCapsule, hard · Oral use30 BlisterSAR 181.30Generic · PrescriptionMS Pharma Saudi (MSPS)Valid
STRATTERA 10MG CAPSULES10 mgCapsule, hard · Oral use28 BlisterSAR 224.55NCE · PrescriptionLilly,S.AValid
STRATTERA 18MG CAPSULES18 mgCapsule, hard · Oral use28 BlisterSAR 224.55NCE · PrescriptionLilly,S.AValid
STRATTERA 25MG CAPSULES25 mgCapsule, hard · Oral use28 BlisterSAR 224.55NCE · PrescriptionLilly,S.AValid
STRATTERA 40MG CAPSULES40 mgCapsule, hard · Oral use28 BlisterSAR 224.55NCE · PrescriptionLilly,S.AValid
STRATTERA 60MG CAPSULES60 mgCapsule, hard · Oral use28 BlisterSAR 224.55NCE · PrescriptionLilly,S.AValid
STRATTERA 10MG CAPSULES10 mgCapsule, hard · Oral use28 BlisterSAR 320.80NCE · PrescriptionSPIMACO ADDWAEIHWithdrawn by MAH · Not Marketed
STRATTERA 18MG CAPSULES18 mgCapsule, hard · Oral use28 BlisterSAR 320.80NCE · PrescriptionSPIMACO ADDWAEIHWithdrawn by MAH · Not Marketed
STRATTERA 25MG CAPSULES25 mgCapsule, hard · Oral use28 BlisterSAR 320.80NCE · PrescriptionSPIMACO ADDWAEIHWithdrawn by MAH · Not Marketed
STRATTERA 40MG CAPSULES40 mgCapsule, hard · Oral use28 BlisterSAR 320.80NCE · PrescriptionSPIMACO ADDWAEIHWithdrawn by MAH · Not Marketed
STRATTERA 60MG CAPSULES60 mgCapsule, hard · Oral use28 BlisterSAR 320.80NCE · PrescriptionSPIMACO ADDWAEIHWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

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

ProductStrengthForm · routeApplicantStatusFirst approved
ATOMOXETINE HYDROCHLORIDEEQ 18MG BASE; EQ 25MG BASE; EQ 40MG BASE; EQ 60MG BASE; EQ 80MG BASE; EQ 100MG BASE; EQ 10MG BASEcapsule · oralZYDUS PHARMS USA INCPrescription16 Sep 2010
ATOMOXETINE HYDROCHLORIDEEQ 10MG BASE; EQ 18MG BASE; EQ 25MG BASE; EQ 40MG BASE; EQ 60MG BASE; EQ 80MG BASE; EQ 100MG BASEcapsule · oralAPOTEXPrescription30 May 2017
ATOMOXETINE HYDROCHLORIDEEQ 10MG BASE; EQ 18MG BASE; EQ 25MG BASE; EQ 40MG BASE; EQ 60MG BASE; EQ 80MG BASE; EQ 100MG BASEcapsule · oralAUROBINDO PHARMAPrescription30 May 2017
ATOMOXETINE HYDROCHLORIDEEQ 10MG BASE; EQ 18MG BASE; EQ 25MG BASE; EQ 40MG BASE; EQ 60MG BASE; EQ 80MG BASE; EQ 100MG BASEcapsule · oralGLENMARK PHARMS LTDPrescription30 May 2017
ATOMOXETINE HYDROCHLORIDEEQ 10MG BASE; EQ 18MG BASE; EQ 25MG BASE; EQ 40MG BASE; EQ 60MG BASE; EQ 80MG BASE; EQ 100MG BASEcapsule · oralTEVA PHARMS USAPrescription30 May 2017
ATOMOXETINE HYDROCHLORIDEEQ 10MG BASE; EQ 18MG BASE; EQ 25MG BASE; EQ 40MG BASE; EQ 60MG BASE; EQ 80MG BASE; EQ 100MG BASEcapsule · oralDR REDDYSPrescription23 Feb 2018
ATOMOXETINE HYDROCHLORIDEEQ 10MG BASE; EQ 18MG BASE; EQ 25MG BASE; EQ 40MG BASE; EQ 60MG BASE; EQ 80MG BASE; EQ 100MG BASEcapsule · oralSTRIDES PHARMAPrescription18 Feb 2021
ATOMOXETINE HYDROCHLORIDEEQ 10MG BASE; EQ 18MG BASE; EQ 25MG BASE; EQ 40MG BASE; EQ 60MG BASE; EQ 80MG BASE; EQ 100MG BASEcapsule · oralHETERO LABS LTD VPrescription11 Mar 2021
ATONCYEQ 4MG BASE/MLsolution · oralMAP77Prescription20 Mar 2026
ATOMOXETINE HYDROCHLORIDEEQ 10MG BASE; EQ 18MG BASE; EQ 25MG BASE; EQ 40MG BASE; EQ 60MG BASE; EQ 80MG BASE; EQ 100MG BASEcapsule · oralPHARMAZONEPrescription16 Jun 2026
STRATTERAEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 18MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**capsule · oralLILLYDiscontinued26 Nov 2002

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-ATOMOXETINE0231802410 MGCAPSULE · ORALAPOTEX INC
APO-ATOMOXETINE0231803218 MGCAPSULE · ORALAPOTEX INC
APO-ATOMOXETINE0231804025 MGCAPSULE · ORALAPOTEX INC
APO-ATOMOXETINE0231805940 MGCAPSULE · ORALAPOTEX INC
APO-ATOMOXETINE0231806760 MGCAPSULE · ORALAPOTEX INC
APO-ATOMOXETINE0231807580 MGCAPSULE · ORALAPOTEX INC
APO-ATOMOXETINE02318083100 MGCAPSULE · ORALAPOTEX INC
ATOMOXETINE0244588310 MGCAPSULE · ORALSIVEM PHARMACEUTICALS ULC
ATOMOXETINE0244590518 MGCAPSULE · ORALSIVEM PHARMACEUTICALS ULC
ATOMOXETINE0244591325 MGCAPSULE · ORALSIVEM PHARMACEUTICALS ULC
ATOMOXETINE0244594840 MGCAPSULE · ORALSIVEM PHARMACEUTICALS ULC
ATOMOXETINE0244595660 MGCAPSULE · ORALSIVEM PHARMACEUTICALS ULC
ATOMOXETINE0246774710 MGCAPSULE · ORALSANIS HEALTH INC
ATOMOXETINE0246775518 MGCAPSULE · ORALSANIS HEALTH INC
ATOMOXETINE0246776325 MGCAPSULE · ORALSANIS HEALTH INC
ATOMOXETINE0246777140 MGCAPSULE · ORALSANIS HEALTH INC
ATOMOXETINE0246779860 MGCAPSULE · ORALSANIS HEALTH INC
ATOMOXETINE0246780180 MGCAPSULE · ORALSANIS HEALTH INC
ATOMOXETINE02467828100 MGCAPSULE · ORALSANIS HEALTH INC
AURO-ATOMOXETINE0247148510 MGCAPSULE · ORALAURO PHARMA INC
AURO-ATOMOXETINE0247149318 MGCAPSULE · ORALAURO PHARMA INC
AURO-ATOMOXETINE0247150725 MGCAPSULE · ORALAURO PHARMA INC
AURO-ATOMOXETINE0247151540 MGCAPSULE · ORALAURO PHARMA INC
AURO-ATOMOXETINE0247152360 MGCAPSULE · ORALAURO PHARMA INC
AURO-ATOMOXETINE0247153180 MGCAPSULE · ORALAURO PHARMA INC

32 more — full table

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACATOMOXETINE HCL 10 MG CAPSULE$0.32216per EA23 Sep 2026
US NADACATOMOXETINE HCL 100 MG CAPSULE$0.51448per EA23 Sep 2026
US NADACATOMOXETINE HCL 18 MG CAPSULE$0.38181per EA23 Sep 2026
US NADACATOMOXETINE HCL 25 MG CAPSULE$0.38297per EA23 Sep 2026
US NADACATOMOXETINE HCL 40 MG CAPSULE$0.44218per EA23 Sep 2026
US NADACATOMOXETINE HCL 60 MG CAPSULE$0.50934per EA23 Sep 2026
US NADACATOMOXETINE HCL 80 MG CAPSULE$0.52256per EA30 Sep 2026
NHS Drug TariffAtomoxetine 100mg capsules£6.6828 capsule1 Oct 2026
NHS Drug TariffAtomoxetine 10mg capsules£11.7328 capsule1 Oct 2026
NHS Drug TariffAtomoxetine 18mg capsules£8.8128 capsule1 Oct 2026
NHS Drug TariffAtomoxetine 25mg capsules£10.9428 capsule1 Oct 2026
NHS Drug TariffAtomoxetine 40mg capsules£5.7328 capsule1 Oct 2026
NHS Drug TariffAtomoxetine 4mg/ml oral solution sugar free£35.33100 ml1 Oct 2026
NHS Drug TariffAtomoxetine 60mg capsules£10.2928 capsule1 Oct 2026
NHS Drug TariffAtomoxetine 80mg capsules£11.8228 capsule1 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.

Safety signals and safety-related labeling changes

All safety entries for atomoxetine →

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.