Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022059
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TYKERB | LAPATINIB DITOSYLATE | EQ 250MG BASE | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/13/2007 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022059s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022059s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/27/2022 | SUPPL-31 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022059s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022059Orig1s031ltr.pdf | |
| 12/06/2018 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022059s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022059s024ltr.pdf | |
| 12/06/2018 | SUPPL-23 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022059s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022059s023ltr.pdf | |
| 04/06/2017 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022059s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022059Orig1s022ltr.pdf | |
| 12/22/2014 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022059Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022059Orig1s021ltr.pdf | |
| 03/31/2015 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022059s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022059Orig1s020ltr.pdf | |
| 06/21/2013 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s015s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022059Orig1s015,s018ltr.pdf | |
| 10/18/2013 | SUPPL-17 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022059Orig1s016,s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022059Orig1s017.pdf | |
| 10/18/2013 | SUPPL-16 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022059Orig1s016,s017ltr.pdf | |
| 06/21/2013 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s015s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022059Orig1s015,s018ltr.pdf | |
| 03/02/2012 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022059s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022059Orig1s013ltr.pdf | |
| 08/12/2011 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022059s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022059s011,s012ltr.pdf | |
| 08/12/2011 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022059s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022059s011,s012ltr.pdf | |
| 01/29/2010 | SUPPL-7 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022059s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022059Orig1s007.pdf | |
| 01/29/2010 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s3s6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022059s003s006ltr.pdf | |
| 07/07/2008 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022059s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022059s004ltr.pdf | |
| 01/29/2010 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s3s6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022059s003s006ltr.pdf | |
| 08/20/2007 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022059s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022059s002ltr.pdf | |
| 04/27/2007 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022059s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022059s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/27/2022 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022059s031lbl.pdf | |
| 03/27/2022 | SUPPL-31 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022059s031lbl.pdf | |
| 12/06/2018 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022059s024lbl.pdf | |
| 12/06/2018 | SUPPL-23 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022059s023lbl.pdf | |
| 04/06/2017 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022059s022lbl.pdf | |
| 03/31/2015 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022059s020lbl.pdf | |
| 12/22/2014 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022059Orig1s021lbl.pdf | |
| 10/18/2013 | SUPPL-17 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s016s017lbl.pdf | |
| 10/18/2013 | SUPPL-16 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s016s017lbl.pdf | |
| 06/21/2013 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s015s018lbl.pdf | |
| 06/21/2013 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022059s015s018lbl.pdf | |
| 03/02/2012 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022059s013lbl.pdf | |
| 08/12/2011 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022059s011s012lbl.pdf | |
| 08/12/2011 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022059s011s012lbl.pdf | |
| 01/29/2010 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s007lbl.pdf | |
| 01/29/2010 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s3s6lbl.pdf | |
| 01/29/2010 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022059s3s6lbl.pdf | |
| 07/07/2008 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022059s004lbl.pdf | |
| 08/20/2007 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022059s002lbl.pdf | |
| 04/27/2007 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022059s001lbl.pdf | |
| 03/13/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022059lbl.pdf |
TYKERB
TABLET;ORAL; EQ 250MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LAPATINIB DITOSYLATE | LAPATINIB DITOSYLATE | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 203007 | NATCO PHARMA LTD |
| TYKERB | LAPATINIB DITOSYLATE | EQ 250MG BASE | TABLET;ORAL | Prescription | Yes | AB | 022059 | NOVARTIS |