Treats attention-deficit/hyperactivity disorder (ADHD). NDA 21411, held by Lilly. Atomoxetine Hydrochloride.
As of Nov 14, 2026, NDA 21411 (Strattera), held by Lilly, was first approved by FDA on Nov 26, 2002, with 36 approved supplements and 0 published complete response letters.
STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD. STRATTERA is a selective norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of ADHD in adults and pediatric patients 6 years of age and older.
| Jul 23, 2008 | Supplement 24Efficacy (new indication or use) · Standard review | Approved | |
| May 7, 2008 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Sep 28, 2007 | Supplement 19Efficacy (new indication or use) | Approved | |
| May 26, 2005 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Nov 26, 2002 | Original applicationNew molecular entity · Standard review | Approved |
| StratteraEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Atomoxetine Hydrochloride | Discontinued |
| StratteraEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Atomoxetine Hydrochloride | DiscontinuedReference drug |
| StratteraEQ 18MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Atomoxetine Hydrochloride | DiscontinuedReference drug |
| StratteraEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Atomoxetine Hydrochloride | DiscontinuedReference drug |
| StratteraEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Atomoxetine Hydrochloride | DiscontinuedReference drug |
| StratteraEQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Atomoxetine Hydrochloride | DiscontinuedReference drug |
| StratteraEQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Atomoxetine Hydrochloride | DiscontinuedReference drug |
| StratteraEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Atomoxetine Hydrochloride | DiscontinuedReference drug |
| Jun 29, 2026 | Supplement 53Labeling · Standard review | Approved | |
| Jan 6, 2022 | Supplement 50Labeling | Approved | |
| Feb 25, 2020 | Supplement 49Labeling · Standard review | Approved | |
| May 19, 2017 | Supplement 48Labeling | Approved | |
| May 26, 2015 | Supplement 46Labeling · Standard review | Approved | |
| Apr 17, 2015 | Supplement 47Labeling · Standard review | Approved | |
| Feb 21, 2014 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Feb 20, 2014 | Supplement 44Labeling · Standard review | Approved | |
| Dec 4, 2013 | Supplement 45Labeling · Standard review | Approved | |
| Aug 5, 2013 | Supplement 42Labeling · Standard review | Approved | |
| Aug 5, 2013 | Supplement 40Labeling · Standard review | Approved | |
| May 20, 2013 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Aug 16, 2012 | Supplement 36Labeling · Standard review | Approved | |
| Jul 5, 2012 | Supplement 34Labeling · Standard review | Approved | |
| Jun 14, 2012 | Supplement 39Labeling · Standard review | Approved | |
| Mar 7, 2011 | Supplement 35Labeling · Standard review | Approved | |
| Jul 29, 2010 | Supplement 32Labeling | Approved | |
| Jun 3, 2009 | Supplement 30Labeling · Standard review | Approved | |
| Jun 3, 2009 | Supplement 29Labeling · Standard review | Approved | |
| Jul 23, 2008 | Supplement 26Labeling · Standard review | Approved | |
| Jul 23, 2008 | Supplement 25Labeling · Standard review | Approved | |
| Jul 23, 2008 | Supplement 24Efficacy (new indication or use) · Standard review | Approved | |
| May 7, 2008 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Sep 28, 2007 | Supplement 19Efficacy (new indication or use) | Approved | |
| Apr 25, 2007 | Supplement 21Labeling · Standard review | Approved | |
| Apr 25, 2007 | Supplement 15Labeling · Standard review | Approved | |
| Apr 25, 2007 | Supplement 13Labeling · Standard review | Approved | |
| Apr 25, 2007 | Supplement 12Labeling · Standard review | Approved | |
| Apr 25, 2007 | Supplement 4Labeling · Standard review | Approved | |
| Oct 19, 2006 | Supplement 18Labeling · Standard review | Approved | |
| Nov 8, 2005 | Supplement 14Labeling · Standard review | Approved | |
| May 26, 2005 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Feb 14, 2005 | Supplement 10Manufacturing · Standard review | Approved | |
| Feb 1, 2005 | Supplement 11Labeling · Standard review | Approved | |
| Feb 1, 2005 | Supplement 2Labeling · Standard review | Approved | |
| Jan 17, 2003 | Supplement 1Labeling · Standard review | Approved | |
| Nov 26, 2002 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
