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Labeler · US market

CELLTRION USA, Inc.

CELLTRION USA, Inc. is a US drug labeler with US FDA registrations covering 16 drug concepts (16 currently active) across 88 packages. It is currently the only active US supplier of 14 drugs. The company files with FDA under 2 name variants, merged into this profile.

Also files as: CELLTRION, Inc.

ACTIVE — US
openFDA · updated weekly
Labeler codes32228 · 72606
Active drugs16
Registrations34 active / 36
Packages88
Sole supplier of14 drugs

Portfolio16 drugs · US

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

DrugTypeNDCsPackagesStatus
Adalimumab-Aaty
kit
rx524SUPPLYING
Infliximab-Dyyb
kit
rx112SUPPLYING
Infliximab-Dyyb
injection, powder, lyophilized, for solution
rx26SUPPLYING
Tocilizumab
injection, solution
rx16SUPPLYING
Tocilizumab
injection, solution, concentrate
rx36SUPPLYING
Tocilizumab
injection, solution
rx36SUPPLYING
Adalimumab-Aaty
injection, solution
other55SUPPLYING
Denosumab-Bmwo
injection
rx44SUPPLYING
Infliximab-Dyyb
injection
other14SUPPLYING
Bevacizumab-Adcd
injection, solution
rx24SUPPLYING
Adalimumab-Aaty
liquid
other13SUPPLYING
Ustekinumab-Stba
injection, solution
rx33SUPPLYING
Bevacizumab-Adcd
injection, solution
other22SUPPLYING
Infliximab-Dyyb
injection, solution
other11SUPPLYING
Infliximab-Dyyb
injection
rx11SUPPLYING
Ustekinumab-Stba
injection, solution
rx11SUPPLYING