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Labeler · US market

Kyowa Kirin, Inc.

Kyowa Kirin, Inc. is a US drug labeler with US FDA registrations covering 6 drug concepts (6 currently active) across 14 packages. It is currently the only active US supplier of 4 drugs. The company files with FDA under 2 name variants, merged into this profile.

Also files as: Kyowa Kirin Co., Ltd.

ACTIVE — US
openFDA · updated weekly
Labeler codes42747 · 45793
Active drugs6
Registrations11 active / 11
Packages14
Sole supplier of4 drugs

Portfolio6 drugs · US

Every drug concept this labeler has US registrations for, by package count.

DrugTypeNDCsPackagesStatus
Istradefylline
tablet, film coated
rx24SUPPLYING
Burosumab
injection
other33SUPPLYING
Burosumab
injection
rx33SUPPLYING
Toremifene Citrate
tablet
rx12SUPPLYING
Mogamulizumab
injection
other11SUPPLYING
Mogamulizumab-Kpkc
injection
rx11SUPPLYING