Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021856
Company: TAKEDA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ULORIC FEBUXOSTAT 40MG TABLET;ORAL Prescription None Yes No
ULORIC FEBUXOSTAT 80MG TABLET;ORAL Prescription None 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
02/13/2009 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021856lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021856s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021856s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021856s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/21/2019 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021856s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021856Orig1s013ltr.pdf
02/06/2018 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021856s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021856Orig1s012ltr.pdf
08/15/2017 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021856s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021856Orig1s011ltr.pdf
02/12/2016 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/23/2014 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/12/2013 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/01/2012 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021856s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021856Orig1s006ltr.pdf
01/28/2011 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021856s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021856s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/21/2019 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021856s013lbl.pdf
02/06/2018 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021856s012lbl.pdf
08/15/2017 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021856s011lbl.pdf
11/01/2012 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021856s006lbl.pdf
01/28/2011 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021856s003lbl.pdf
02/13/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021856lbl.pdf

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