Drugs@FDA: FDA Approved Drug Products
New Drug Application (NDA): 021411
Company: LILLY
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 | Submission Classification |
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-Package Insert, Labeling-Medication Guide |
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 | Submission Classification 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021411s035lbl.pdf | |
| 03/07/2011 | SUPPL-35 | Labeling-Medication Guide | 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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