FDA.reportPublic FDA data

Application 021856

Type
NDA
Sponsor
TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ULORICFEBUXOSTATTABLET;ORAL40MGYesNo
002ULORICFEBUXOSTATTABLET;ORAL80MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-516ULORICfebuxostatRebel Distributors CorpNDACurrent
43353-305ULORICfebuxostatAphena Pharma Solutions - Tennessee, LLCNDACurrent
43353-305ULORICfebuxostatAphena Pharma Solutions - Tennessee, LLCNDACurrent
55154-5158ULORICfebuxostatCardinal HealthNDACurrent
55154-5158ULORICfebuxostatCardinal HealthNDACurrent
55154-5158ULORICfebuxostatCardinal HealthNDACurrent
55154-5159ULORICfebuxostatCardinal HealthNDACurrent
55154-5159ULORICfebuxostatCardinal HealthNDACurrent
55154-5159ULORICfebuxostatCardinal HealthNDACurrent
64764-677ULORICfebuxostatTakeda Pharmaceuticals America, Inc.NDACurrent
64764-677ULORICfebuxostatTakeda Pharmaceuticals America, Inc.NDACurrent
64764-677ULORICfebuxostatTakeda Pharmaceuticals America, Inc.NDACurrent
64764-677ULORICfebuxostatTakeda Pharmaceuticals AmNDACurrent
64764-918ULORICfebuxostatTakeda Pharmaceuticals America, Inc.NDACurrent
64764-918ULORICfebuxostatTakeda Pharmaceuticals America, Inc.NDACurrent
64764-918ULORICfebuxostatTakeda Pharmaceuticals America, Inc.NDACurrent
64764-918ULORICfebuxostatTakeda Pharmaceuticals AmNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74019SUPPL 2023-04-19
74018SUPPL 2023-04-19
57852SUPPL2019-02-28
57768SUPPL2019-02-22
57751SUPPL2019-02-22
52516SUPPL2018-02-08
52496SUPPL2018-02-07
49568SUPPL2017-08-29
49426SUPPL2017-08-16
28716SUPPL2012-11-06
16461SUPPL2012-11-02
16460SUPPL2011-02-04
6310SUPPL2011-02-03
42327ORIG2009-04-07
24221ORIG2009-04-07
16459ORIG2009-02-20
28715ORIG2009-02-18