KINRIX is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Glaxosmithkline Biologicals Sa. The primary component is Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated); Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated); Bordetella Pertussis Filamentous Hemagglutinin Antigen (formaldehyde Inactivated); Bordetella Pertussis Pertactin Antigen (formaldehyde Inactivated); Bordetella Pertussis Toxoid Antigen (formaldehyde, Glutaraldehyde Inactivated); Poliovirus Type 1 Antigen (formaldehyde Inactivated); Poliovirus Type 2 Antigen (formaldehyde Inactivated); Poliovirus Type 3 Antigen (formaldehyde Inactivated).
Product ID | 58160-812_24ddfd99-cdb4-4eca-8b45-78b143f3b22c |
NDC | 58160-812 |
Product Type | Vaccine |
Proprietary Name | KINRIX |
Generic Name | Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine |
Dosage Form | Injection, Suspension |
Route of Administration | INTRAMUSCULAR |
Marketing Start Date | 2008-07-09 |
Marketing Category | BLA / BLA |
Application Number | BLA125260 |
Labeler Name | GlaxoSmithKline Biologicals SA |
Substance Name | CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) |
Active Ingredient Strength | 25 [iU]/.5mL; [iU]/.5mL; [iU]/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL |
Pharm Classes | Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Diphtheria Toxoid [CS],Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Tetanus Toxoid [CS],Pertussis Vaccine [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pertussis Vaccine [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [CS],Vaccines, Inactivated [CS],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccines [CS],Vaccines, Inactivated [CS] |
NDC Exclude Flag | N |
Listing Certified Through | 2019-12-31 |
Marketing Start Date | 2008-07-09 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | BLA |
Application Number | BLA125260 |
Product Type | VACCINE |
Marketing Start Date | 2010-06-04 |
Marketing End Date | 2013-06-06 |
Marketing Category | BLA |
Application Number | BLA125260 |
Product Type | VACCINE |
Billing Unit | ML |
Marketing Start Date | 2010-08-25 |
Marketing Category | BLA |
Application Number | BLA125260 |
Product Type | VACCINE |
Billing Unit | ML |
Marketing Start Date | 2008-07-09 |
Marketing Category | BLA |
Application Number | BLA125260 |
Product Type | VACCINE |
Marketing Start Date | 2008-07-09 |
Marketing End Date | 2013-06-06 |
Marketing Category | BLA |
Application Number | BLA125260 |
Product Type | VACCINE |
Billing Unit | ML |
Marketing Start Date | 2010-08-25 |
Marketing Category | BLA |
Application Number | BLA125260 |
Product Type | VACCINE |
Marketing Start Date | 2008-07-09 |
Marketing End Date | 2013-06-06 |
Marketing Category | BLA |
Application Number | BLA125260 |
Product Type | VACCINE |
Billing Unit | ML |
Marketing Start Date | 2008-07-09 |
Ingredient | Strength |
---|---|
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) | 25 [iU]/.5mL |
NDC | Brand Name | Generic Name |
---|---|---|
58160-812 | KINRIX | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine |
49281-562 | QUADRACEL | diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine |
49281-564 | QUADRACEL | diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
KINRIX 77339855 4053321 Live/Registered |
GlaxoSmithKline Biologicals, S.A. 2007-11-29 |
KINRIX 77339851 3696442 Live/Registered |
GlaxoSmithKline Biologicals, S.A. 2007-11-29 |
KINRIX 77339669 not registered Dead/Abandoned |
GlaxoSmithKline Biologicals, S.A. 2007-11-29 |
KINRIX 77009573 3664020 Live/Registered |
GlaxoSmithKline Biologicals S.A. 2006-09-28 |