Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021882
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EXJADE DEFERASIROX 125MG TABLET, FOR SUSPENSION;ORAL Prescription AB Yes No
EXJADE DEFERASIROX 250MG TABLET, FOR SUSPENSION;ORAL Prescription AB Yes No
EXJADE DEFERASIROX 500MG TABLET, FOR SUSPENSION;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
11/02/2005 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021882lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021882ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021882_s000_ExjadeTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/16/2018 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021882s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021882Orig1s026ltr.pdf
05/11/2018 SUPPL-25 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021882s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021882Orig1s025ltr.pdf
08/12/2016 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021882s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021882Orig1s024ltr.pdf
07/23/2015 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021882s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021882Orig1s021ltr.pdf
10/21/2013 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021882s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021882Orig1s019ltr.pdf
11/01/2013 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/29/2013 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021882s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021882Orig1s017ltr.pdf
01/23/2013 SUPPL-16 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021882Orig1s015,s016ltr.pdf
01/23/2013 SUPPL-15 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021882s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021882Orig1s015,s016ltr.pdf
09/14/2012 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021882s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021882Orig1s014ltr.pdf
08/10/2011 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021882s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021882s012ltr.pdf
04/11/2011 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021882s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021882s011ltr.pdf
01/28/2010 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021882s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021882s010ltr.pdf
03/05/2009 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021882s007ltr.pdf
04/22/2009 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021882s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021882s006ltr.pdf
10/02/2008 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021882s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021882s004ltr.pdf
12/21/2007 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021882s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021882s003ltr.pdf
04/20/2007 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021882s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021882s002lltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/11/2018 SUPPL-25 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021882s025lbl.pdf
02/16/2018 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021882s026lbl.pdf
08/12/2016 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021882s024lbl.pdf
07/23/2015 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021882s021lbl.pdf
10/21/2013 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021882s019lbl.pdf
05/29/2013 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021882s017lbl.pdf
01/23/2013 SUPPL-15 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021882s015lbl.pdf
09/14/2012 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021882s014lbl.pdf
08/10/2011 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021882s012lbl.pdf
04/11/2011 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021882s011lbl.pdf
01/28/2010 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021882s010lbl.pdf
04/22/2009 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021882s006lbl.pdf
10/02/2008 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021882s004lbl.pdf
12/21/2007 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021882s003lbl.pdf
04/20/2007 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021882s002lbl.pdf
11/02/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021882lbl.pdf

EXJADE

TABLET, FOR SUSPENSION;ORAL; 125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEFERASIROX DEFERASIROX 125MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 203560 ACTAVIS ELIZABETH
EXJADE DEFERASIROX 125MG TABLET, FOR SUSPENSION;ORAL Prescription Yes AB 021882 NOVARTIS

TABLET, FOR SUSPENSION;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEFERASIROX DEFERASIROX 250MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 203560 ACTAVIS ELIZABETH
EXJADE DEFERASIROX 250MG TABLET, FOR SUSPENSION;ORAL Prescription Yes AB 021882 NOVARTIS

TABLET, FOR SUSPENSION;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEFERASIROX DEFERASIROX 500MG TABLET, FOR SUSPENSION;ORAL Prescription No AB 203560 ACTAVIS ELIZABETH
EXJADE DEFERASIROX 500MG TABLET, FOR SUSPENSION;ORAL Prescription Yes AB 021882 NOVARTIS

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