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 6 Vaccine Injection

Brand(s)
Gardasil
Category(s)
other
SPL Type(s)
Vaccine
Master SPL
Merck Sharp & Dohme Corp. (2015-04-24)
Oldest Current Product
2006-06-08
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 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 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 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 0.08 mg/ml / l1 protein, human papillomavirus type 18 vaccine 0.04 mg/ml / l1 protein, human papillomavirus type 6 vaccine 0.04 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000064045GardasilBLAMerck Sharp & Dohme Corp.2006-06-08HUMAN 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 6 L1 CAPSID PROTEIN ANTIGENINTRAMUSCULARINJECTION, SUSPENSION12512630952400-0572-4431-9150-3a41affffb9a

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250833GardasilBLARemedyrepack Inc.2014-02-13HUMAN 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 6 L1 CAPSID PROTEIN ANTIGENINTRAMUSCULARINJECTION, SUSPENSION00006404512512646a2bb5a-57f7-4747-a10f-488b2a60990d

application(s)

#idtitleapprovedtradenamesfda division
1125126Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine Recombinant Application2006-06-08GARDASILCBER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)in other drug docs
130952400-0572-4431-9150-3a41affffb9a (view SPL)These highlights do not include all the information needed to use GARDASIL safely and effectively. See full prescribing information for GARDASIL. GARDASIL[Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]Suspension for intramuscular injection Initial U.S. Approval: 2006otherVaccineMerck Sharp & Dohme Corp.2015-04-2423000064045, 000064109L1 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 6 Vaccine Prefilled Syringe
246a2bb5a-57f7-4747-a10f-488b2a60990d (view SPL)These highlights do not include all the information needed to use GARDASIL safely and effectively. See full prescribing information for GARDASIL.GARDASIL[Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]Suspension for intramuscular injectionInitial U.S. Approval: 2006otherVaccineRemedyrepack Inc.2014-02-132521250833

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