FDA.reportPublic FDA data

Application 209606

Type
NDA
Sponsor
CELGENE CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IDHIFAENASIDENIB MESYLATETABLET;ORALEQ 50MG BASEYesNo
002IDHIFAENASIDENIB MESYLATETABLET;ORALEQ 100MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59572-705Idhifaenasidenib mesylateCelgene CorporationNDACurrent
59572-705Idhifaenasidenib mesylateCelgene CorporationNDACurrent
59572-705Idhifaenasidenib mesylateCelgene CorporationNDACurrent
59572-705Idhifaenasidenib mesylateCelgene CorporationNDACurrent
59572-705Idhifaenasidenib mesylateCelgene CorporationNDACurrent
59572-710Idhifaenasidenib mesylateCelgene CorporationNDACurrent
59572-710Idhifaenasidenib mesylateCelgene CorporationNDACurrent
59572-710Idhifaenasidenib mesylateCelgene CorporationNDACurrent
59572-710Idhifaenasidenib mesylateCelgene CorporationNDACurrent
59572-710Idhifaenasidenib mesylateCelgene CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80868SUPPL 2025-01-17
80864SUPPL 2025-01-17
80863SUPPL 2025-01-17
80643SUPPL 2024-12-19
77120SUPPL 2023-12-22
77111SUPPL 2023-12-22
68210SUPPL2021-07-27
65357SUPPL2020-11-27
65333SUPPL2020-11-25
65332SUPPL2020-11-25
60186SUPPL2019-10-01
60185SUPPL2019-10-01
60162SUPPL2019-09-30
49522ORIG2017-08-24
49208ORIG2017-08-02
49171ORIG2017-08-01
49170ORIG2017-08-01