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)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 492810589 | Menactra | BLA | Sanofi Pasteur Inc. | 2005-01-14 | 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 | INTRAMUSCULAR | INJECTION, SOLUTION | 125089 | 4d8781ff-9366-462c-8161-6e958f44fcb4 |
relabeler product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 521250836 | Menactra | BLA | Remedyrepack Inc. | 2015-01-03 | 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 | INTRAMUSCULAR | INJECTION, SOLUTION | 492810589 | 125089 | c94555e9-2ec6-4bc8-8018-c2e79d009c37 |
application(s)
| # | id | title | approved | fda division |
|---|---|---|---|---|
| 1 | 125089 | Meningococcal Groups (A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate VaccineMenactra Application | 2005-01-14 | CBER |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 4d8781ff-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: 2005 | other | Vaccine | Sanofi Pasteur Inc. | MANUFACTURE | 2014-08-31 | 6 | 492810589 |
| 2 | c94555e9-2ec6-4bc8-8018-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: 2005 | other | Vaccine | Remedyrepack Inc. | 2015-01-03 | 1 | 521250836 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII