NDC 33332-421
Afluria Quadrivalent
Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/cambodia/e0826360/2020 Ivr-224 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/victoria/705/2018 Bvr-11 Antigen (propiolactone Inactivated), Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated)
Afluria Quadrivalent is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Seqirus Pty Ltd.. The primary component is Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (propiolactone Inactivated); Influenza A Virus A/cambodia/e0826360/2020 Ivr-224 (h3n2) Antigen (propiolactone Inactivated); Influenza B Virus B/victoria/705/2018 Bvr-11 Antigen (propiolactone Inactivated); Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated).
| Product ID | 33332-421_3b0bcd63-a057-4b2f-a636-49da7f8c9949 |
| NDC | 33332-421 |
| Product Type | Vaccine |
| Proprietary Name | Afluria Quadrivalent |
| Generic Name | Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/cambodia/e0826360/2020 Ivr-224 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/victoria/705/2018 Bvr-11 Antigen (propiolactone Inactivated), Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated) |
| Dosage Form | Injection, Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2021-07-02 |
| Marketing End Date | 2022-07-31 |
| Marketing Category | BLA / |
| Application Number | BLA125254 |
| Labeler Name | Seqirus PTY LTD. |
| Substance Name | INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/CAMBODIA/E0826360/2020 IVR-224 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| Active Ingredient Strength | 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |
| NDC Exclude Flag | N |
Packaging
NDC 33332-421-10
1 VIAL, MULTI-DOSE in 1 CARTON (33332-421-10) > 5 mL in 1 VIAL, MULTI-DOSE (33332-421-11)
| Marketing Start Date | 2021-07-02 |
| Marketing End Date | 2022-07-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
Drug Details
NDC Crossover Matching brand name "Afluria Quadrivalent" or generic name "Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/cambodia/e0826360/2020 Ivr-224 (h3n2) Antigen (propiolactone Inactivated), Influenza B Virus B/victoria/705/2018 Bvr-11 Antigen (propiolactone Inactivated), Influenza B Virus B/phuket/3073/2013 Bvr-1b Antigen (propiolactone Inactivated)"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 33332-219 | Afluria Quadrivalent | INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-220 | Afluria Quadrivalent | INFLUENZA A VIRUS A/VICTORIA/2454/2019 IVR-207 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-221 | Afluria Quadrivalent | INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/CAMBODIA/E0826360/2020 IVR-224 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-318 | AFLURIA QUADRIVALENT | INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED), AND INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-319 | Afluria Quadrivalent | INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-320 | Afluria Quadrivalent | INFLUENZA A VIRUS A/VICTORIA/2454/2019 IVR-207 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-321 | Afluria Quadrivalent | INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/CAMBODIA/E0826360/2020 IVR-224 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-322 | Afluria Quadrivalent | INFLUENZA A VIRUS A/Victoria/2570/2019 IVR-215 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Darwin/6/2021 IVR-227 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Austria/1359417/2021 BVR-26 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Phuket/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-418 | AFLURIA QUADRIVALENT | INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED), AND INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-419 | Afluria Quadrivalent | INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-420 | Afluria Quadrivalent | INFLUENZA A VIRUS A/VICTORIA/2454/2019 IVR-207 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-421 | Afluria Quadrivalent | INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/CAMBODIA/E0826360/2020 IVR-224 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
| 33332-422 | Afluria Quadrivalent | INFLUENZA A VIRUS A/Victoria/2570/2019 IVR-215 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Darwin/6/2021 IVR-227 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Austria/1359417/2021 BVR-26 ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Phuket/3073/2013 BVR-1B ANTIGEN (PROPIOLACTONE INACTIVATED) |
Trademark Results [Afluria Quadrivalent]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AFLURIA QUADRIVALENT 87684481 5676287 Live/Registered |
CSL Limited 2017-11-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.