FDA.reportPublic FDA data

Application 210461

Type
ANDA
Sponsor
MSN

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
68071-5271FebuxostatFebuxostatNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5271FebuxostatFebuxostatNuCare Pharmaceuticals,Inc.ANDACurrent
69539-035FebuxostatFebuxostatMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-035FebuxostatFebuxostatMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-036FebuxostatFebuxostatMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-036FebuxostatFebuxostatMSN LABORATORIES PRIVATE LIMITEDANDACurrent
71610-411FebuxostatFebuxostatAphena Pharma Solutions - Tennessee, LLCANDACurrent
72205-028FebuxostatFebuxostatNovadoz Pharmaceuticals LLCANDACurrent
72205-028FebuxostatFebuxostatNovadoz Pharmaceuticals LLCANDACurrent
72205-028FebuxostatFebuxostatNovadoz Pharmaceuticals LLCANDACurrent
72205-029FebuxostatFebuxostatNovadoz Pharmaceuticals LLCANDACurrent
72205-029FebuxostatFebuxostatNovadoz Pharmaceuticals LLCANDACurrent
72205-029FebuxostatFebuxostatNovadoz Pharmaceuticals LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59241ORIG2019-07-05