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INFANRIX - Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed

Navigation: NDC > Supplier starting with: G > GLAXOSMITHKLINE BIOLOGICALS SA
Field Value
NDC Code: 58160-810
Proprietary Name: INFANRIX
Suffix:
Non-Proprietary Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
Dosage Form: SUSPENSION
Method: INTRAMUSCULAR
Original Marketing Date: 24-07-2009
Category Name: BLA
Application Number: BLA103647
Labeler: GLAXOSMITHKLINE BIOLOGICALS SA
Substance Name: BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)
Active Numerator Strength: 25; 8; 25; 10; 25
Active Ingredient Unit: ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL
Pharm Classes: Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient]
DEA Schedule: