Influenza A virus vaccine, A-California-7-2009 (H1N1)-like virus / Influenza A virus vaccine, A-Victoria-361-2011 (H3N2)-like virus / Influenza B virus vaccine, B-Wisconsin-1-2010-like virus Injectable Solution
- Brand(s)
- Flublok 2012-2013 Formula
- Category(s)
- other
- SPL Type(s)
- Vaccine
- Master SPL
- Protein Sciences Corporation (2013-01-25)
- Oldest Current Product
- 2013-02-01
- License(s)
- BLA
- RxNORM
- INJECTABLE SOLUTION\INFLUENZA A VIRUS VACCINE, A-CALIFORNIA-7-2009 (H1N1)-LIKE VIRUS:INFLUENZA A VIRUS VACCINE, A-VICTORIA-361-2011 (H3N2)-LIKE VIRUS:INFLUENZA B VIRUS VACCINE, B-WISCONSIN-1-2010-LIKE VIRUS
- SPL Active
- INTRAMUSCULAR\INJECTION, SOLUTION\INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN: INFLUENZA A VIRUS A/VICTORIA/361/2011 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN: INFLUENZA B VIRUS B/WISCONSIN/1/2010 RECOMBINANT HEMAGGLUTININ ANTIGEN
- SPL Moiety
- INTRAMUSCULAR\INJECTION, SOLUTION\INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN: INFLUENZA A VIRUS A/VICTORIA/361/2011 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN: INFLUENZA B VIRUS B/WISCONSIN/1/2010 RECOMBINANT HEMAGGLUTININ ANTIGEN
product(s) by strength(s)
influenza a virus vaccine, a-california-7-2009 (h1n1)-like virus 0.09 mg/ml / influenza a virus vaccine, a-victoria-361-2011 (h3n2)-like virus 0.09 mg/ml / influenza b virus vaccine, b-wisconsin-1-2010-like virus 0.09 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 428740012 | Flublok 2012-2013 Formula | BLA | Protein Sciences Corporation | 2013-02-01 | INFLUENZA A VIRUS A/CALIFORNIA/7/2009 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA A VIRUS A/VICTORIA/361/2011 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA B VIRUS B/WISCONSIN/1/2010 RECOMBINANT HEMAGGLUTININ ANTIGEN | INTRAMUSCULAR | INJECTION, SOLUTION | 125285 | e8aa934c-d74e-4c7c-b2fc-d3b8b46f4529 |
application(s)
| # | id | title | approved | fda division |
|---|---|---|---|---|
| 1 | 125285 | Influenza VaccineFluBlok Application | 2013-01-16 | CBER |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | e8aa934c-d74e-4c7c-b2fc-d3b8b46f4529 (view SPL) | These highlights do not include all the information needed to use Flublok safely and effectively. See full prescribing information for Flublok. Flublok (Influenza Vaccine) Sterile Solution for Intramuscular Injection 2012-2013 FormulaInitial U.S. Approval: 2013 | other | Vaccine | Protein Sciences Corporation | ANALYSIS, MANUFACTURE | 2013-01-25 | 1 | 428740012 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII