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Labeler · US market

GlaxoSmithKline Biologicals SA

GlaxoSmithKline Biologicals SA is a US drug labeler with US FDA registrations covering 20 drug concepts (19 currently active) across 27 packages. It is currently the only active US supplier of 11 drugs.

ACTIVE — US
openFDA · updated weekly
Labeler codes58160
Active drugs19
Registrations24 active / 25
Packages27
Sole supplier of11 drugs

Portfolio20 drugs · US

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

DrugTypeNDCsPackagesStatus
Hepatitis B Vaccine (Recombinant)
injection, suspension
other23SUPPLYING
Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted
kit
other33SUPPLYING
Tetanus Toxoid, Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine, Adsorbed
suspension
other12SUPPLYING
Haemophilus B Conjugate Vaccine (Tetanus Toxoid Conjugate)
kit
other22SUPPLYING
Hepatitis A Vaccine
injection, suspension
other22SUPPLYING
Meningococcal (Groups A, C, Y And W-135) Oligosaccharide Diphtheria Crm197 Conjugate Vaccine
injection, solution
other11SUPPLYING
Influenza A H5 Monovalent Vaccine
kit
other11SUPPLYING
Hepatitis A And Hepatitis B (Recombinant) Vaccine
injection, suspension
other11SUPPLYING
Zoster Vaccine Recombinant, Adjuvanted
kit
other11SUPPLYING
As03
injection, solution
other11SUPPLYING
Diphtheria And Tetanus Toxoids And Acellular Pertussis Vaccine Adsorbed
suspension
other11SUPPLYING
Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) And Inactivated Poliovirus Vaccine Combined
injection, suspension
other11SUPPLYING
Rotavirus Vaccine, Live, Oral
solution
other11SUPPLYING
Meningococcal (Groups A, B, C, W And Y)
kit
other11SUPPLYING
Zoster Vaccine Recombinant, Adjuvanted
injection, solution
other11SUPPLYING
Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine
injection, suspension
other11SUPPLYING
Measels, Mumps, And Rubella Vaccine, Live
kit
other11SUPPLYING
Meningococcal (Groups A, C, Y And W-135) Oligosaccharide Diphtheria Crm197 Conjugate Vaccine
kit
other11SUPPLYING
Neisseria Meningitidis Serogroup B Nhba Fusion Protein Antigen, Neisseria Meningitidis Serogroup B Fhbp Fusion Protein Antigen And Neisseria Meningitidis Serogroup B Nada Protein Antigen
injection, suspension
other11SUPPLYING
Influenza Virus Vaccine
suspension
other11DISCONTINUED