Flulaval Quadrivalent
- Product NDC
- 19515-897
- 11-digit product format
- 195150897
- Labeler code
- 19515
- Product ID
- 19515-897_2a9a9563-8797-4c1f-acbf-d2c4ef974e87
- Type
- VACCINE
- Nonproprietary name
- influenza virus vaccine
- Dosage form
- SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- ID Biomedical Corporation of Quebec
- Application
- BLA125163
- Marketing category
- BLA
- Marketing start
- 2019-07-02
- Marketing end
- 2020-06-30
- Substance
- INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (UV, FORMALDEHYDE INACTIVATED)
- Active strength
- 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125163 | Flulaval, Flulaval Quadrivalent | Influenza Vaccine | 351(a) | Rx | 2026-06-01 |