FDA.reportPublic FDA data

Application 761090

Type
BLA
Sponsor
DYAX CORP.

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TAKHZYROLANADELUMAB (SHP643)INJECTABLE;INJECTION300MG/ML(150MG/ML)NoNo
002TAKHZYROLANDELUMAB-FLYOSOLUTION;SUBCUTANEOUS300MG/2ML (150MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47783-644TAKHZYROlanadelumab-flyoDyax Corp.BLACurrent
47783-644TAKHZYROlanadelumab-flyoTakeda Pharmaceuticals America, Inc.BLACurrent
47783-644TAKHZYROlanadelumab-flyoDyax Corp.BLACurrent
47783-644TAKHZYROlanadelumab-flyoTakeda Pharmaceuticals America, Inc.BLACurrent
47783-644TAKHZYROlanadelumab-flyoTakeda Pharmaceuticals America, Inc.BLACurrent
47783-646TAKHZYROlanadelumab-flyoTakeda Pharmaceuticals America, Inc.BLACurrent
47783-646TAKHZYROlanadelumab-flyoTakeda Pharmaceuticals America, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73395SUPPL 2023-02-07
73388SUPPL 2023-02-06
71191SUPPL2022-06-01
56520SUPPL2018-11-20
56506SUPPL2018-11-20
55532ORIG2018-09-20
55507ORIG2018-09-18
55283ORIG2018-08-24