Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022068
Company: NOVARTIS
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 | |
| 02/29/2024 | SUPPL-40 | Manufacturing (CMC)-Facility |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022068Orig1s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022068Orig1s040ltr.pdf | |
| 02/06/2024 | SUPPL-39 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022068Orig1s039lbl.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 |
|---|---|---|---|---|---|
| 02/29/2024 | SUPPL-40 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022068Orig1s040lbl.pdf | |
| 02/08/2024 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022068s041lbl.pdf | |
| 02/06/2024 | SUPPL-39 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022068Orig1s039lbl.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 |