Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203469
Company: ARIAD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ICLUSIG PONATINIB HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Prescription None Yes No
ICLUSIG PONATINIB HYDROCHLORIDE EQ 45MG BASE TABLET;ORAL Prescription None Yes Yes
ICLUSIG PONATINIB HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription None 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
12/14/2012 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203469lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203469Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203469Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203469Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/07/2016 SUPPL-24 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203469Orig1s024ltr.pdf
08/31/2016 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203469Orig1s023ltr.pdf
11/28/2016 SUPPL-22 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203469Orig1s022ltr.pdf
06/02/2016 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203469Orig1s021ltr.pdf
12/02/2015 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203469s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203469Orig1s020ltr.pdf
12/01/2015 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/24/2015 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/23/2015 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/17/2015 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/20/2015 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/03/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/20/2015 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/09/2014 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/15/2014 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/30/2014 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/24/2014 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203469s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203469Orig1s009ltr.pdf
12/20/2013 SUPPL-8 REMS-Proposal Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203469s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203469Orig1s007,s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203469Orig1s007,s008.pdf
12/20/2013 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203469s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203469Orig1s007,s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203469Orig1s007,s008.pdf
03/27/2014 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/30/2014 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/12/2013 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/25/2013 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/28/2016 SUPPL-22 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s022lbl.pdf
09/07/2016 SUPPL-24 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s024lbl.pdf
08/31/2016 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s023lbl.pdf
06/02/2016 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203469s021lbl.pdf
12/02/2015 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203469s020lbl.pdf
07/24/2014 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203469s009lbl.pdf
12/20/2013 SUPPL-8 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203469s007s008lbl.pdf
12/20/2013 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203469s007s008lbl.pdf
12/14/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203469lbl.pdf

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