L1 protein, Human papillomavirus type 11 Vaccine / L1 protein, Human papillomavirus type 16 Vaccine / L1 protein, Human papillomavirus type 18 Vaccine / L1 protein, Human papillomavirus type 31 Vaccine / L1 protein, Human papillomavirus type 33 Vaccine / L1 protein, Human papillomavirus type 45 Vaccine / L1 protein, Human papillomavirus type 52 Vaccine / L1 protein, Human papillomavirus type 58 Vaccine / L1 protein, Human papillomavirus type 6 Vaccine Injection

Brand(s)
Gardasil 9
Category(s)
other
SPL Type(s)
Vaccine
Master SPL
Merck Sharp & Dohme Corp. (2015-08-06)
Oldest Current Product
2014-12-10
License(s)
BLA
RxNORM
INJECTION\L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 11 VACCINE:L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 16 VACCINE:L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 18 VACCINE:L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 31 VACCINE:L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 33 VACCINE:L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 45 VACCINE:L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 52 VACCINE:L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 58 VACCINE:L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 6 VACCINE
SPL Active
INTRAMUSCULAR\INJECTION, SUSPENSION\HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN
SPL Moiety
INTRAMUSCULAR\INJECTION, SUSPENSION\HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN: HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN

product(s) by strength(s)

0.5 ml l1 protein, human papillomavirus type 11 vaccine 0.08 mg/ml / l1 protein, human papillomavirus type 16 vaccine 0.12 mg/ml / l1 protein, human papillomavirus type 18 vaccine 0.08 mg/ml / l1 protein, human papillomavirus type 31 vaccine 0.04 mg/ml / l1 protein, human papillomavirus type 33 vaccine 0.04 mg/ml / l1 protein, human papillomavirus type 45 vaccine 0.04 mg/ml / l1 protein, human papillomavirus type 52 vaccine 0.04 mg/ml / l1 protein, human papillomavirus type 58 vaccine 0.04 mg/ml / l1 protein, human papillomavirus type 6 vaccine 0.06 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000064119Gardasil 9BLAMerck Sharp & Dohme Corp.2014-12-10HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN, HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN, HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN, HUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGEN, HUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN, HUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN, HUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN, HUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN, HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGENINTRAMUSCULARINJECTION, SUSPENSION125508a21f4f4b-b891-4f25-b747-cb9ec7d865d6

application(s)

#idtitleapprovedfda division
1125508Human Papillomavirus 9-valent Vaccine, RecombinantGardasil 9 Application2014-12-10CBER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)in other drug docs
1a21f4f4b-b891-4f25-b747-cb9ec7d865d6 (view SPL)These highlights do not include all the information needed to use GARDASIL 9 safely and effectively. See full prescribing information for GARDASIL 9. GARDASIL9 (Human Papillomavirus 9-valent Vaccine, Recombinant) Suspension for intramuscular injection Initial U.S. Approval: 2014otherVaccineMerck Sharp & Dohme Corp.2015-08-065000064119, 000064121L1 protein, Human papillomavirus type 11 Vaccine / L1 protein, Human papillomavirus type 16 Vaccine / L1 protein, Human papillomavirus type 18 Vaccine / L1 protein, Human papillomavirus type 31 Vaccine / L1 protein, Human papillomavirus type 33 Vaccine / L1 protein, Human papillomavirus type 45 Vaccine / L1 protein, Human papillomavirus type 52 Vaccine / L1 protein, Human papillomavirus type 58 Vaccine / L1 protein, Human papillomavirus type 6 Vaccine Prefilled Syringe

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII