Neisseria meningitidis serogroup A capsular polysaccharide diphtheria toxoid protein conjugate vaccine / Neisseria meningitidis serogroup C capsular polysaccharide diphtheria toxoid protein conjugate vaccine / Neisseria meningitidis serogroup W-135 capsular polysaccharide diphtheria toxoid protein conjugate vaccine / Neisseria meningitidis serogroup Y capsular polysaccharide diphtheria toxoid protein conjugate vaccine Injection

Brand(s)
Menactra
Category(s)
other
SPL Type(s)
Vaccine
Master SPL
Sanofi Pasteur Inc. (2014-08-31)
Oldest Current Product
2005-01-14
License(s)
BLA
RxNORM
INJECTION\NEISSERIA MENINGITIDIS SEROGROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID PROTEIN CONJUGATE VACCINE:NEISSERIA MENINGITIDIS SEROGROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID PROTEIN CONJUGATE VACCINE:NEISSERIA MENINGITIDIS SEROGROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID PROTEIN CONJUGATE VACCINE:NEISSERIA MENINGITIDIS SEROGROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID PROTEIN CONJUGATE VACCINE
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN: NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN: NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN: NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN: NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN: NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN: NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN

product(s) by strength(s)

0.5 ml neisseria meningitidis serogroup a capsular polysaccharide diphtheria toxoid protein conjugate vaccine 0.104 mg/ml / neisseria meningitidis serogroup c capsular polysaccharide diphtheria toxoid protein conjugate vaccine 0.104 mg/ml / neisseria meningitidis serogroup w-135 capsular polysaccharide diphtheria toxoid protein conjugate vaccine 0.104 mg/ml / neisseria meningitidis serogroup y capsular polysaccharide diphtheria toxoid protein conjugate vaccine 0.104 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1492810589MenactraBLASanofi Pasteur Inc.2005-01-14NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGENINTRAMUSCULARINJECTION, SOLUTION1250894d8781ff-9366-462c-8161-6e958f44fcb4

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250836MenactraBLARemedyrepack Inc.2015-01-03NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGENINTRAMUSCULARINJECTION, SOLUTION492810589125089c94555e9-2ec6-4bc8-8018-c2e79d009c37

application(s)

#idtitleapprovedfda division
1125089Meningococcal Groups (A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate VaccineMenactra Application2005-01-14CBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14d8781ff-9366-462c-8161-6e958f44fcb4 (view SPL)These highlights do not include all the information needed to use Menactra safely and effectively. See full prescribing information for Menactra vaccine. Menactra, Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine Solution for Intramuscular Injection Initial U.S. Approval: 2005otherVaccineSanofi Pasteur Inc.MANUFACTURE2014-08-316492810589
2c94555e9-2ec6-4bc8-8018-c2e79d009c37 (view SPL)These highlights do not include all the information needed to use Menactra safely and effectively. See full prescribing information for Menactra vaccine. Menactra, Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine Solution for Intramuscular Injection Initial U.S. Approval: 2005otherVaccineRemedyrepack Inc.2015-01-031521250836

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