Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021588
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GLEEVEC | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
| GLEEVEC | IMATINIB MESYLATE | EQ 400MG 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 |
|---|---|---|---|---|---|---|---|
| 04/18/2003 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21588ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021588s000_GleevecTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/01/2024 | SUPPL-63 | Manufacturing (CMC)-Facility |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021588Orig1s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021588Orig1s063ltr.pdf | |
| 08/19/2022 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021588s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021588Orig1s062ltr.pdf | |
| 03/24/2022 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021588s060lbl.pdf | |
| 08/10/2020 | SUPPL-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021588s056s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021588Orig1s056,s057ltr.pdf | |
| 08/10/2020 | SUPPL-56 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021588s056s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021588Orig1s056,s057ltr.pdf | |
| 08/21/2018 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021588s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021588Orig1s053ltr.pdf | |
| 09/29/2017 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021588s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021588Orig1s052ltr.pdf | |
| 09/06/2017 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021588s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021588orig1s051ltr.pdf | |
| 04/24/2017 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021588s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021588Orig1s049ltr.pdf | |
| 09/27/2016 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021588s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021588Orig1s047ltr.pdf | |
| 08/25/2016 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021588s045s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021588Orig1s045,s046ltr.pdf | |
| 08/25/2016 | SUPPL-45 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021588s045s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021588Orig1s045,s046ltr.pdf | |
| 01/30/2015 | SUPPL-42 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021588s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021588Orig1s042ltr.pdf | |
| 05/22/2014 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021588s040lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021588Orig1s040ltr.pdf | |
| 10/30/2013 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021588s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021588Orig1s039ltr.pdf | |
| 02/21/2013 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021588s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021588Orig1s038ltr.pdf | |
| 01/25/2013 | SUPPL-37 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021588s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021588Orig1s037ltr.pdf | |
| 01/31/2012 | SUPPL-35 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021588s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021588s035ltr_cor.pdf | |
| 04/01/2011 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021588s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021588s030,s031ltr.pdf | |
| 04/01/2011 | SUPPL-30 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021588s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021588s030,s031ltr.pdf | |
| 05/27/2009 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021588s026s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021588s026,021588s028ltr.pdf | |
| 02/10/2009 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021588s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021588s027ltr.pdf | |
| 05/27/2009 | SUPPL-26 | Efficacy-Accelerated Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021588s026,021588s028ltr.pdf |
| 12/19/2008 | SUPPL-25 | Efficacy-New Indication |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s025ltr.pdf |
| 09/26/2008 | SUPPL-24 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s024ltr.pdf | |
| 04/30/2008 | SUPPL-23 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s023ltr.pdf |
| 09/26/2008 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s022ltr.pdf | |
| 09/26/2008 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s021ltr.pdf | |
| 09/13/2007 | SUPPL-20 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021588s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021588s020ltr.pdf | |
| 10/19/2006 | SUPPL-17 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s017_gleevec.pdf | |
| 09/27/2006 | SUPPL-16 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s016ltr.pdf | |
| 10/19/2006 | SUPPL-14 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s014_gleevec.pdf | |
| 10/19/2006 | SUPPL-13 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s013_gleevic.pdf | |
| 10/19/2006 | SUPPL-12 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s012_gleevic.pdf | |
| 10/19/2006 | SUPPL-11 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s011, s012, s013, s014, s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s011_gleevec.pdf | |
| 05/31/2006 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s008, s010LTR.pdf | |
| 10/30/2006 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021588s009ltr.pdf | |
| 10/20/2005 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021588s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021588s008ltr.pdf | |
| 05/18/2005 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021588s007ltr.pdf |
| 05/19/2005 | SUPPL-6 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021588s006ltr.pdf |
| 03/14/2005 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21588s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21588s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021588_s005_GLEVAC.pdf | |
| 06/23/2004 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21588slr003_gleevec_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21588slr003ltr.pdf | |
| 12/08/2003 | SUPPL-2 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21588se7-002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-588s002_Gleevec.cfm | |
| 05/20/2003 | SUPPL-1 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21588se5-001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-335s003_21-588s001_Gleevec.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/01/2024 | SUPPL-63 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021588Orig1s063lbl.pdf | |
| 08/19/2022 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021588s062lbl.pdf | |
| 03/24/2022 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021588s060lbl.pdf | |
| 08/10/2020 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021588s056s057lbl.pdf | |
| 08/10/2020 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021588s056s057lbl.pdf | |
| 08/21/2018 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021588s053lbl.pdf | |
| 09/29/2017 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021588s052lbl.pdf | |
| 09/06/2017 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021588s051lbl.pdf | |
| 04/24/2017 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021588s049lbl.pdf | |
| 09/27/2016 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021588s047lbl.pdf | |
| 08/25/2016 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021588s045s046lbl.pdf | |
| 08/25/2016 | SUPPL-45 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021588s045s046lbl.pdf | |
| 01/30/2015 | SUPPL-42 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021588s042lbl.pdf | |
| 05/22/2014 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021588s040lbledt.pdf | |
| 10/30/2013 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021588s039lbl.pdf | |
| 02/21/2013 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021588s038lbl.pdf | |
| 01/25/2013 | SUPPL-37 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021588s037lbl.pdf | |
| 01/31/2012 | SUPPL-35 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021588s035lbl.pdf | |
| 04/01/2011 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021588s030s031lbl.pdf | |
| 04/01/2011 | SUPPL-30 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021588s030s031lbl.pdf | |
| 05/27/2009 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021588s026s028lbl.pdf | |
| 02/10/2009 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021588s027lbl.pdf | |
| 09/26/2008 | SUPPL-24 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf | |
| 09/26/2008 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf | |
| 09/26/2008 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021588s024lbl.pdf | |
| 09/13/2007 | SUPPL-20 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021588s020lbl.pdf | |
| 10/30/2006 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s009lbl.pdf | |
| 10/19/2006 | SUPPL-17 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf | |
| 10/19/2006 | SUPPL-14 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf | |
| 10/19/2006 | SUPPL-13 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf | |
| 10/19/2006 | SUPPL-12 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf | |
| 10/19/2006 | SUPPL-11 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s011s012s013s014s017lbl.pdf | |
| 09/27/2006 | SUPPL-16 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s016lbl.pdf | |
| 05/31/2006 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021588s010lbl.pdf | |
| 10/20/2005 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021588s008lbl.pdf | |
| 03/14/2005 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21588s005lbl.pdf | |
| 06/23/2004 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21588slr003_gleevec_lbl.pdf | |
| 12/08/2003 | SUPPL-2 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588s002lbl.pdf | |
| 05/20/2003 | SUPPL-1 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588s001lbl.pdf | |
| 04/18/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588lbl.pdf |
GLEEVEC
TABLET;ORAL; EQ 100MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GLEEVEC | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021588 | NOVARTIS |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 079179 | APOTEX |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 208429 | CHARTWELL RX |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 206547 | DR REDDYS |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 212773 | EUGIA PHARMA |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 204644 | MYLAN |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 207818 | NATCO PHARMA LTD |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 212135 | QILU PHARM HAINAN |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 208302 | SHILPA |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 078340 | SUN PHARM |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 204285 | TEVA PHARMS USA |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 210658 | ZYDUS PHARMS |
TABLET;ORAL; EQ 400MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GLEEVEC | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021588 | NOVARTIS |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 079179 | APOTEX |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 208429 | CHARTWELL RX |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 206547 | DR REDDYS |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 212773 | EUGIA PHARMA |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 204644 | MYLAN |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 207818 | NATCO PHARMA LTD |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 212135 | QILU PHARM HAINAN |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 208302 | SHILPA |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 078340 | SUN PHARM |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 204285 | TEVA PHARMS USA |
| IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 210658 | ZYDUS PHARMS |