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New Drug Application (NDA): 022068
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TASIGNA NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE;ORAL Prescription AB Yes Yes
TASIGNA NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Prescription AB Yes No
TASIGNA NILOTINIB HYDROCHLORIDE EQ 50MG BASE 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
10/29/2007 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022068s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022068TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022068s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/08/2024 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022068s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022068Orig1s041Correctedltr.pdf
02/18/2022 SUPPL-37 Manufacturing (CMC)-Facility Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022068Orig1s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022068Orig1s037ltr.pdf
09/23/2021 SUPPL-36 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022068s035s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022068Orig1s035, 036ltr.pdf
09/23/2021 SUPPL-35 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022068s035s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022068Orig1s035, 036ltr.pdf
12/08/2020 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022068s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022068Orig1s033ltr.pdf
09/25/2019 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022068s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022068Orig1s031ltr.pdf
08/21/2018 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022068s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022068Orig1s029ltr.pdf
03/22/2018 SUPPL-27 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022068s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022068Orig1s027ltr.pdf
12/22/2017 SUPPL-26 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022068s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022068Orig1s026ltr.pdf
02/21/2017 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022068s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022068Orig1s024ltr.pdf
09/27/2016 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022068s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022068Orig1s023ltr.pdf
10/15/2015 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022068s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022068Orig1s021ltr.pdf
01/27/2015 SUPPL-20 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022068s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022068Orig1s020ltr.pdf
09/25/2014 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022068s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022068Orig1s019ltr.pdf
09/27/2013 SUPPL-18 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022068s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022068Orig1s018ltr.pdf
01/22/2014 SUPPL-17 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022068s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022068Orig1s017ltr.pdf
05/22/2013 SUPPL-16 REMS-Assessment Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022068Orig1s016ltr.pdf
08/14/2013 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/13/2013 SUPPL-14 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022068s014lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022068Orig1s014ltr_corrected.pdf
05/17/2013 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022068Orig1s013ltr.pdf
05/01/2012 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022068s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022068s012ltr.pdf
12/20/2012 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022068s011lbledt2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022068Orig1s011ltr.pdf
11/18/2011 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022068s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022068s008,s009ltr.pdf
11/18/2011 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022068s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022068s008,s009ltr.pdf
10/26/2011 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022068s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022068Orig1s007ltr.pdf
01/14/2011 SUPPL-6 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022068s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022068s006ltr.pdf
06/17/2010 SUPPL-5 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022068s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022068s004,s005ltr.pdf
06/17/2010 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022068s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022068s004,s005ltr.pdf
08/21/2009 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022068s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022068s002ltr.pdf
03/15/2010 SUPPL-1 Labeling, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022068s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022068s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/08/2024 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022068s041lbl.pdf
02/18/2022 SUPPL-37 Manufacturing (CMC)-Facility Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022068Orig1s037lbl.pdf
09/23/2021 SUPPL-36 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022068s035s036lbl.pdf
09/23/2021 SUPPL-35 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022068s035s036lbl.pdf
12/08/2020 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022068s033lbl.pdf
09/25/2019 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022068s031lbl.pdf
08/21/2018 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022068s029lbl.pdf
03/22/2018 SUPPL-27 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022068s027lbl.pdf
12/22/2017 SUPPL-26 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022068s026lbl.pdf
02/21/2017 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022068s024lbl.pdf
09/27/2016 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022068s023lbl.pdf
10/15/2015 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022068s021lbl.pdf
01/27/2015 SUPPL-20 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022068s020lbl.pdf
09/25/2014 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022068s019lbl.pdf
01/22/2014 SUPPL-17 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022068s017lbl.pdf
09/27/2013 SUPPL-18 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022068s018lbl.pdf
09/27/2013 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022068s018lbl.pdf
06/13/2013 SUPPL-14 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022068s014lbledt.pdf
12/20/2012 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022068s011lbledt2.pdf
05/01/2012 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022068s012lbl.pdf
11/18/2011 SUPPL-9 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022068s008s009lbl.pdf
11/18/2011 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022068s008s009lbl.pdf
11/18/2011 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022068s008s009lbl.pdf
10/26/2011 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022068s007lbl.pdf
01/14/2011 SUPPL-6 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022068s006lbl.pdf
06/17/2010 SUPPL-5 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022068s004s005lbl.pdf
06/17/2010 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022068s004s005lbl.pdf
03/15/2010 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022068s001lbl.pdf
03/15/2010 SUPPL-1 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022068s001lbl.pdf
08/21/2009 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022068s002lbl.pdf
10/29/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022068lbl.pdf

TASIGNA

CAPSULE;ORAL; EQ 200MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NILOTINIB HYDROCHLORIDE NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE;ORAL Prescription No AB 203640 APOTEX
TASIGNA NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE;ORAL Prescription Yes AB 022068 NOVARTIS

CAPSULE;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NILOTINIB HYDROCHLORIDE NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 203640 APOTEX
TASIGNA NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Prescription Yes AB 022068 NOVARTIS

CAPSULE;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NILOTINIB HYDROCHLORIDE NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 203640 APOTEX
TASIGNA NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Prescription Yes AB 022068 NOVARTIS
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