GARDASIL is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by A-s Medication Solutions. The primary component is Human Papillomavirus Type 6 L1 Capsid Protein Antigen; Human Papillomavirus Type 11 L1 Capsid Protein Antigen; Human Papillomavirus Type 16 L1 Capsid Protein Antigen; Human Papillomavirus Type 18 L1 Capsid Protein Antigen.
Product ID | 50090-1523_0150b986-99af-492a-a1de-0b1b2a33a4f5 |
NDC | 50090-1523 |
Product Type | Vaccine |
Proprietary Name | GARDASIL |
Generic Name | Human Papillomavirus Quadrivalent (types 6, 11, 16, And 18) Vaccine, Recombinant |
Dosage Form | Injection, Suspension |
Route of Administration | INTRAMUSCULAR |
Marketing Start Date | 2006-06-08 |
Marketing Category | BLA / BLA |
Application Number | BLA125126 |
Labeler Name | A-S Medication Solutions |
Substance Name | HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN |
Active Ingredient Strength | 20 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |
Pharm Classes | Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [CS],Vaccines, Inactivated [CS] |
NDC Exclude Flag | N |
Listing Certified Through | 2021-12-31 |
Marketing Start Date | 2006-06-08 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | BLA |
Application Number | BLA125126 |
Product Type | VACCINE |
Marketing Start Date | 2006-06-08 |
Marketing Category | BLA |
Application Number | BLA125126 |
Product Type | VACCINE |
Marketing Start Date | 2006-06-08 |
Ingredient | Strength |
---|---|
HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN | 20 ug/.5mL |
NDC | Brand Name | Generic Name |
---|---|---|
0006-4045 | GARDASIL | Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant |
0006-4109 | GARDASIL | Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant |
50090-1523 | GARDASIL | Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GARDASIL 76563892 3015981 Live/Registered |
MERCK SHARP & DOHME CORP. 2003-12-05 |