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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021856
Company: TAKEDA PHARMS USA

Medication Guide

Summary Review

Products on NDA 021856

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ULORIC	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	AB	Yes	No
ULORIC	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021856

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
04/17/2023	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021856s015lbl.pdf
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

Labels for NDA 021856

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/17/2023	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021856s015lbl.pdf
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

Therapeutic Equivalents for NDA 021856

ULORIC

TABLET;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	205421	ALEMBIC
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	212924	ALKEM LABS LTD
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	205374	DR REDDYS
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	205414	HIKMA
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	210292	INDOCO
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	210461	MSN
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	205385	MYLAN
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	206266	PRINSTON INC
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	205467	SUN PHARM
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	213069	SUNSHINE
FEBUXOSTAT	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	No	AB	205443	ZYDUS LIFESCIENCES
ULORIC	FEBUXOSTAT	40MG	TABLET;ORAL	Prescription	Yes	AB	021856	TAKEDA PHARMS USA

TABLET;ORAL; 80MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	205421	ALEMBIC
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	212924	ALKEM LABS LTD
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	205374	DR REDDYS
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	205414	HIKMA
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	210292	INDOCO
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	210461	MSN
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	205385	MYLAN
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	206266	PRINSTON INC
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	205467	SUN PHARM
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	213069	SUNSHINE
FEBUXOSTAT	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	No	AB	205443	ZYDUS LIFESCIENCES
ULORIC	FEBUXOSTAT	80MG	TABLET;ORAL	Prescription	Yes	AB	021856	TAKEDA PHARMS USA

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