FDA.reportPublic FDA data

Application 205414

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FEBUXOSTATFEBUXOSTATTABLET;ORAL40MGNoNo
002FEBUXOSTATFEBUXOSTATTABLET;ORAL80MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0413FebuxostatFebuxostatHikma Pharmaceuticals USA IncANDACurrent
0054-0413FebuxostatFebuxostatHikma Pharmaceuticals USA IncANDACurrent
0054-0414FebuxostatFebuxostatHikma Pharmaceuticals USA IncANDACurrent
0054-0414FebuxostatFebuxostatHikma Pharmaceuticals USA IncANDACurrent
51407-293FebuxostatFebuxostatGolden State Medical Supply Inc.ANDACurrent
51407-294FebuxostatFebuxostatGolden State Medical Supply Inc.ANDACurrent
71610-386FebuxostatFebuxostatAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-450FebuxostatFebuxostatAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
46174ORIG2016-12-15