FDA.reportPublic FDA data

Application 212327

Type
NDA
Sponsor
IMPACT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INREBICFEDRATINIB HYDROCHLORIDECAPSULE;ORALEQ 100MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59572-720InrebicFedratinib HydrochlorideCelgene CorporationNDACurrent
59572-720InrebicFedratinib HydrochlorideCelgene CorporationNDACurrent
59572-720InrebicFedratinib HydrochlorideCelgene CorporationNDACurrent
59572-720InrebicFedratinib HydrochlorideCelgene CorporationNDACurrent
59572-720InrebicFedratinib HydrochlorideCelgene CorporationNDACurrent
59572-720InrebicFedratinib HydrochlorideCelgene CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85512SUPPL 2026-03-24
85485SUPPL 2026-03-24
85425SUPPL 2026-03-20
82208SUPPL 2025-05-21
82178SUPPL 2025-05-14
79263SUPPL 2024-08-02
79261SUPPL 2024-07-30
74270SUPPL 2023-05-16
74258SUPPL 2023-05-16
69502SUPPL2021-12-07
69487SUPPL2021-12-07
69486SUPPL2021-12-07
69416SUPPL2021-11-24
69415SUPPL2021-11-24
69403SUPPL2021-11-24
60011ORIG2019-09-16
59760ORIG2019-09-16
59728ORIG2019-08-16
59727ORIG2019-08-16