Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021411
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STRATTERA ATOMOXETINE HYDROCHLORIDE 5MG CAPSULE;ORAL Discontinued None No No
STRATTERA ATOMOXETINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription AB Yes No
STRATTERA ATOMOXETINE HYDROCHLORIDE 18MG CAPSULE;ORAL Prescription AB Yes No
STRATTERA ATOMOXETINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription AB Yes No
STRATTERA ATOMOXETINE HYDROCHLORIDE 40MG CAPSULE;ORAL Prescription AB Yes No
STRATTERA ATOMOXETINE HYDROCHLORIDE 60MG CAPSULE;ORAL Prescription AB Yes Yes
STRATTERA ATOMOXETINE HYDROCHLORIDE 80MG CAPSULE;ORAL Prescription AB Yes No
STRATTERA ATOMOXETINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription AB Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/26/2002 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21411_strattera_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21411ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-411_Strattera.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/19/2017 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021411s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021411Orig1s048ltr.pdf
04/17/2015 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021411s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021411Orig1s047ltr.pdf
05/26/2015 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021411s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021411Orig1s046ltr.pdf
12/04/2013 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021411s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021411Orig1s045ltr.pdf
02/20/2014 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021411s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021411Orig1s044ltr.pdf
02/21/2014 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

08/05/2013 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021411s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021411Orig1s040,s042ltr.pdf
05/20/2013 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

08/05/2013 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021411s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021411Orig1s040,s042ltr.pdf
06/14/2012 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021411s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021411s039ltr.pdf
08/16/2012 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021411s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021411Orig1s036ltr.pdf
03/07/2011 SUPPL-35 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021411s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021411s035ltr.pdf
07/05/2012 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021411s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021411s034ltr.pdf
07/29/2010 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021411s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021411s032ltr.pdf
06/03/2009 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021411s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021411s029,s030ltr.pdf
06/03/2009 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021411s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021411s029,s030ltr.pdf
07/23/2008 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021411s024s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021411s024,s025,s026ltr.pdf
07/23/2008 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021411s024s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021411s024,s025,s026ltr.pdf
07/23/2008 SUPPL-24 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021411s024s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021411s024,s025,s026ltr.pdf
04/25/2007 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021411s004,s012,s013,s015,s021ltr.pdf
09/28/2007 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021411s019ltr.pdf
10/19/2006 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021411s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021411s018ltr.pdf
04/25/2007 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021411s004,s012,s013,s015,s021ltr.pdf
11/08/2005 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021411s014ltr.pdf
04/25/2007 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021411s004,s012,s013,s015,s021ltr.pdf
04/25/2007 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021411s004,s012,s013,s015,s021ltr.pdf
02/01/2005 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21411s002,011ltr.pdf
02/14/2005 SUPPL-10 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21411s010ltr.pdf
05/26/2005 SUPPL-8 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021411s008ltr.pdf
05/07/2008 SUPPL-5 Efficacy-New Indication Letter (PDF)
Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021411se1-005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021411se1-005_SUMR.pdf
04/25/2007 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021411s004,s012,s013,s015,s021ltr.pdf
02/01/2005 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21411s002,011ltr.pdf
01/17/2003 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21411slr001_strattera_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21411slr001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021411_S001_STRATTERA_CAPSULES_AP.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/19/2017 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021411s048lbl.pdf
05/26/2015 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021411s046lbl.pdf
04/17/2015 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021411s047lbl.pdf
02/20/2014 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021411s044lbl.pdf
12/04/2013 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021411s045lbl.pdf
08/05/2013 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021411s042lbl.pdf
08/05/2013 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021411s040lbl.pdf
08/16/2012 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021411s036lbl.pdf
07/05/2012 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021411s034lbl.pdf
06/14/2012 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021411s039lbl.pdf
03/07/2011 SUPPL-35 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021411s035lbl.pdf
03/07/2011 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021411s035lbl.pdf
07/29/2010 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021411s032lbl.pdf
06/03/2009 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021411s029s030lbl.pdf
06/03/2009 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021411s029s030lbl.pdf
07/23/2008 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021411s024s025s026lbl.pdf
07/23/2008 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021411s024s025s026lbl.pdf
07/23/2008 SUPPL-24 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021411s024s025s026lbl.pdf
09/28/2007 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s019lbl.pdf
04/25/2007 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf
04/25/2007 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf
04/25/2007 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf
04/25/2007 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf
04/25/2007 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021411s004s012s013s015s021lbl.pdf
10/19/2006 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021411s018lbl.pdf
01/17/2003 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21411slr001_strattera_lbl.pdf
11/26/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21411_strattera_lbl.pdf

STRATTERA

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription No AB 078983 APOTEX INC
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription No AB 079016 AUROBINDO PHARMA LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription No AB 079019 GLENMARK PHARMS LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription No AB 079022 TEVA PHARMS USA
STRATTERA ATOMOXETINE HYDROCHLORIDE 10MG CAPSULE;ORAL Prescription Yes AB 021411 LILLY

CAPSULE;ORAL; 18MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 18MG CAPSULE;ORAL Prescription No AB 078983 APOTEX INC
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 18MG CAPSULE;ORAL Prescription No AB 079016 AUROBINDO PHARMA LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 18MG CAPSULE;ORAL Prescription No AB 079019 GLENMARK PHARMS LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 18MG CAPSULE;ORAL Prescription No AB 079022 TEVA PHARMS USA
STRATTERA ATOMOXETINE HYDROCHLORIDE 18MG CAPSULE;ORAL Prescription Yes AB 021411 LILLY

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 078983 APOTEX INC
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 079016 AUROBINDO PHARMA LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 079019 GLENMARK PHARMS LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 079022 TEVA PHARMS USA
STRATTERA ATOMOXETINE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription Yes AB 021411 LILLY

CAPSULE;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 40MG CAPSULE;ORAL Prescription No AB 078983 APOTEX INC
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 40MG CAPSULE;ORAL Prescription No AB 079016 AUROBINDO PHARMA LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 40MG CAPSULE;ORAL Prescription No AB 079019 GLENMARK PHARMS LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 40MG CAPSULE;ORAL Prescription No AB 079022 TEVA PHARMS USA
STRATTERA ATOMOXETINE HYDROCHLORIDE 40MG CAPSULE;ORAL Prescription Yes AB 021411 LILLY

CAPSULE;ORAL; 60MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 60MG CAPSULE;ORAL Prescription No AB 078983 APOTEX INC
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 60MG CAPSULE;ORAL Prescription No AB 079016 AUROBINDO PHARMA LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 60MG CAPSULE;ORAL Prescription No AB 079019 GLENMARK PHARMS LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 60MG CAPSULE;ORAL Prescription No AB 079022 TEVA PHARMS USA
STRATTERA ATOMOXETINE HYDROCHLORIDE 60MG CAPSULE;ORAL Prescription Yes AB 021411 LILLY

CAPSULE;ORAL; 80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 80MG CAPSULE;ORAL Prescription No AB 078983 APOTEX INC
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 80MG CAPSULE;ORAL Prescription No AB 079016 AUROBINDO PHARMA LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 80MG CAPSULE;ORAL Prescription No AB 079019 GLENMARK PHARMS LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 80MG CAPSULE;ORAL Prescription No AB 079022 TEVA PHARMS USA
STRATTERA ATOMOXETINE HYDROCHLORIDE 80MG CAPSULE;ORAL Prescription Yes AB 021411 LILLY

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription No AB 078983 APOTEX INC
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription No AB 079016 AUROBINDO PHARMA LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription No AB 079019 GLENMARK PHARMS LTD
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription No AB 079022 TEVA PHARMS USA
STRATTERA ATOMOXETINE HYDROCHLORIDE 100MG CAPSULE;ORAL Prescription Yes AB 021411 LILLY

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