← FDA DRUG APPROVALS

FDA NDA · NDA021411

STRATTERA

atomoxetine hydrochloride

Sponsor: LILLY

APPLICATION
NDA021411
TYPE
NDA
ORIGINAL APPROVAL
2002-11-26
LATEST ACTION
2026-06-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

STRATTERA · ReferenceDiscontinued
ATOMOXETINE HYDROCHLORIDE EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
STRATTERA · ReferenceDiscontinued
ATOMOXETINE HYDROCHLORIDE EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
STRATTERA · ReferenceDiscontinued
ATOMOXETINE HYDROCHLORIDE EQ 18MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
STRATTERADiscontinued
ATOMOXETINE HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
STRATTERA · ReferenceDiscontinued
ATOMOXETINE HYDROCHLORIDE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
STRATTERA · ReferenceDiscontinued
ATOMOXETINE HYDROCHLORIDE EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
STRATTERA · ReferenceDiscontinued
ATOMOXETINE HYDROCHLORIDE EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
STRATTERA · ReferenceDiscontinued
ATOMOXETINE HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2026-06-29Labeling · Supplement 53 · standard — Letter ↗AP
2022-01-06Labeling · Supplement 50 · 901 required — Label ↗AP
2020-02-25Labeling · Supplement 49 · standard — Letter ↗AP
2017-05-19Labeling · Supplement 48 · 901 required — Label ↗AP
2015-05-26Labeling · Supplement 46 · standard — Label ↗AP
2015-04-17Labeling · Supplement 47 · standard — Letter ↗AP
2014-02-21Manufacturing (CMC) · Supplement 43 · standardAP
2014-02-20Labeling · Supplement 44 · standard — Label ↗AP
2013-12-04Labeling · Supplement 45 · standard — Letter ↗AP
2013-08-05Labeling · Supplement 42 · standard — Label ↗AP
2013-08-05Labeling · Supplement 40 · standard — Letter ↗AP
2013-05-20Manufacturing (CMC) · Supplement 41 · standardAP
2012-08-16Labeling · Supplement 36 · standard — Label ↗AP
2012-07-05Labeling · Supplement 34 · standard — Letter ↗AP
2012-06-14Labeling · Supplement 39 · standard — Letter ↗AP
2011-03-07Labeling · Supplement 35 · standard — Letter ↗AP
2010-07-29Labeling · Supplement 32 · unknown — Label ↗AP
2009-06-03Labeling · Supplement 29 · standard — Label ↗AP
2009-06-03Labeling · Supplement 30 · standard — Label ↗AP
2008-07-23Labeling · Supplement 25 · standard — Label ↗AP
2008-07-23Labeling · Supplement 26 · standard — Letter ↗AP
2008-07-23Efficacy · Supplement 24 · standard — Letter ↗AP
2008-05-07Efficacy · Supplement 5 · standard — Summary Review ↗AP
2007-09-28Efficacy · Supplement 19 · unknown — Label ↗AP
2007-04-25Labeling · Supplement 15 · standard — Letter ↗AP
2007-04-25Labeling · Supplement 21 · standard — Letter ↗AP
2007-04-25Labeling · Supplement 13 · standard — Letter ↗AP
2007-04-25Labeling · Supplement 12 · standard — Letter ↗AP
2007-04-25Labeling · Supplement 4 · standard — Letter ↗AP
2006-10-19Labeling · Supplement 18 · standard — Label ↗AP
2005-11-08Labeling · Supplement 14 · standard — Letter ↗AP
2005-05-26Efficacy · Supplement 8 · standard — Letter ↗AP
2005-02-14Manufacturing (CMC) · Supplement 10 · standard — Letter ↗AP
2005-02-01Labeling · Supplement 11 · standard — Letter ↗AP
2005-02-01Labeling · Supplement 2 · standard — Letter ↗AP
2003-01-17Labeling · Supplement 1 · standard — Label ↗AP
2002-11-26Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →