| 63552-722-10 |
63552-722 |
VACCINE |
FLUZONE HIGH DOSE NORTHERN HEMISPHERE |
influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/croatia/10136/rv/2023 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated) |
INJECTION, SUSPENSION |
INTRAMUSCULAR |
20250901 |
N/A |
BLA |
BLA103914 |
Patheon Manufacturing Services LLC |
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
60 ug/.5mL; 60 ug/.5mL; 60 ug/.5mL |
5 SYRINGE, GLASS in 1 PACKAGE (63552-722-10) / .5 mL in 1 SYRINGE, GLASS (63552-722-05) |
| 49281-325-50 |
49281-325 |
VACCINE |
FLUZONE TRIVALENT SOUTHERN HEMISPHERE |
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
INJECTION, SUSPENSION |
INTRAMUSCULAR |
20250306 |
20251231 |
BLA |
BLA103914 |
Sanofi Pasteur Inc. |
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
15 ug/.5mL; 15 ug/.5mL; 15 ug/.5mL |
10 SYRINGE, GLASS in 1 PACKAGE (49281-325-50) / .5 mL in 1 SYRINGE, GLASS (49281-325-88) |
| 49281-341-50 |
49281-341 |
VACCINE |
FLUZONE HD TIV SH 2025 |
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
INJECTION, SUSPENSION |
INTRAMUSCULAR |
20250306 |
20251231 |
BLA |
BLA103914 |
Sanofi Pasteur Inc. |
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
60 ug/.5mL; 60 ug/.5mL; 60 ug/.5mL |
10 SYRINGE, GLASS in 1 PACKAGE (49281-341-50) / .5 mL in 1 SYRINGE, GLASS (49281-341-88) |
| 49281-356-15 |
49281-356 |
VACCINE |
FLUZONE TIV SH 2025 |
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED),and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
INJECTION, SUSPENSION |
INTRAMUSCULAR |
20250306 |
20251231 |
BLA |
BLA103914 |
Sanofi Pasteur Inc. |
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
15 ug/.5mL; 15 ug/.5mL; 15 ug/.5mL |
1 VIAL, MULTI-DOSE in 1 PACKAGE (49281-356-15) / 5 mL in 1 VIAL, MULTI-DOSE (49281-356-78) |
| 49281-357-15 |
49281-357 |
VACCINE |
Fluzone QIV SH 2025 |
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
INJECTION, SUSPENSION |
INTRAMUSCULAR |
20250306 |
20251231 |
BLA |
BLA103914 |
Sanofi Pasteur Inc. |
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) |
15 ug/.5mL; 15 ug/.5mL; 15 ug/.5mL; 15 ug/.5mL |
1 VIAL, MULTI-DOSE in 1 PACKAGE (49281-357-15) / 5 mL in 1 VIAL, MULTI-DOSE (49281-357-78) |
| 49281-425-50 |
49281-425 |
VACCINE |
FLUZONE TRIVALENT NORTHERN HEMISPHERE |
INFLUENZA A VIRUS A/Victoria/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136/RV/2023 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
INJECTION, SUSPENSION |
INTRAMUSCULAR |
20240701 |
N/A |
BLA |
BLA103914 |
Sanofi Pasteur Inc. |
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
15 ug/.5mL; 15 ug/.5mL; 15 ug/.5mL |
10 SYRINGE, GLASS in 1 PACKAGE (49281-425-50) / .5 mL in 1 SYRINGE, GLASS (49281-425-88) |
| 49281-541-15 |
49281-541 |
VACCINE |
Fluzone Quadrivalent Northern Hemisphere |
INFLUENZA A VIRUS A/Victoria/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136RV/2023 X-425A ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
INJECTION, SUSPENSION |
INTRAMUSCULAR |
20250701 |
20260630 |
BLA |
BLA103914 |
Sanofi Pasteur Inc. |
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) |
15 ug/.5mL; 15 ug/.5mL; 15 ug/.5mL; 15 ug/.5mL |
1 VIAL, MULTI-DOSE in 1 PACKAGE (49281-541-15) / 5 mL in 1 VIAL, MULTI-DOSE (49281-541-78) |
| 49281-643-15 |
49281-643 |
VACCINE |
FLUZONE TRIVALENT NORTHERN HEMISPHERE |
INFLUENZA A VIRUS A/Victoria/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136/RV/2023 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
INJECTION, SUSPENSION |
INTRAMUSCULAR |
20250701 |
20260630 |
BLA |
BLA103914 |
Sanofi Pasteur Inc. |
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
15 ug/.5mL; 15 ug/.5mL; 15 ug/.5mL |
1 VIAL, MULTI-DOSE in 1 PACKAGE (49281-643-15) / 5 mL in 1 VIAL, MULTI-DOSE (49281-643-78) |
| 49281-926-50 |
49281-926 |
VACCINE |
Fluzone Quadrivalent Northern Hemisphere |
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
INJECTION, SUSPENSION |
INTRAMUSCULAR |
20250701 |
20260630 |
BLA |
BLA103914 |
Sanofi Pasteur Inc. |
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) |
15 ug/.5mL; 15 ug/.5mL; 15 ug/.5mL; 15 ug/.5mL |
10 SYRINGE, GLASS in 1 PACKAGE (49281-926-50) / .5 mL in 1 SYRINGE, GLASS (49281-926-88) |
| 49281-935-50 |
49281-935 |
VACCINE |
FLUZONE HD QUADRIVALENT SOUTHERN HEMISPHERE |
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), andINFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
INJECTION, SUSPENSION |
INTRAMUSCULAR |
20250306 |
20251231 |
BLA |
BLA103914 |
Sanofi Pasteur Inc. |
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) |
60 ug/.7mL; 60 ug/.7mL; 60 ug/.7mL; 60 ug/.7mL |
10 SYRINGE, GLASS in 1 PACKAGE (49281-935-50) / .7 mL in 1 SYRINGE, GLASS (49281-935-88) |
| 49281-226-65 |
49281-226 |
VACCINE |
Fluzone High-Dose Quadrivalent Northern Hemisphere |
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
INJECTION, SUSPENSION |
INTRAMUSCULAR |
20250701 |
20260630 |
BLA |
BLA103914 |
Sanofi Pasteur Inc. |
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) |
60 ug/.7mL; 60 ug/.7mL; 60 ug/.7mL; 60 ug/.7mL |
10 SYRINGE, GLASS in 1 PACKAGE (49281-226-65) / .7 mL in 1 SYRINGE, GLASS (49281-226-88) |
| 49281-125-65 |
49281-125 |
VACCINE |
FLUZONE HIGH DOSE NORTHERN HEMISPHERE |
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136/RV/2023 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
INJECTION, SUSPENSION |
INTRAMUSCULAR |
20250701 |
20260630 |
BLA |
BLA103914 |
Sanofi Pasteur Inc. |
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
60 ug/.5mL; 60 ug/.5mL; 60 ug/.5mL |
5 SYRINGE, GLASS in 1 PACKAGE (49281-125-65) / .5 mL in 1 SYRINGE, GLASS (49281-125-88) |
| 49281-326-50 |
49281-326 |
VACCINE |
FLUZONE QIV SH 2025 |
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
INJECTION, SUSPENSION |
INTRAMUSCULAR |
20250306 |
20251231 |
BLA |
BLA103914 |
Sanofi Pasteur Inc. |
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) |
15 ug/.5mL; 15 ug/.5mL; 15 ug/.5mL; 15 ug/.5mL |
10 SYRINGE, GLASS in 1 PACKAGE (49281-326-50) / .5 mL in 1 SYRINGE, GLASS (49281-326-88) |
| 83703-044-50 |
83703-044 |
VACCINE |
FLUZONE QUADRIVALENT NORTHERN HEMISPHERE |
INFLUENZA A VIRUS A/Victoria/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
INJECTION, SUSPENSION |
INTRAMUSCULAR |
20220701 |
N/A |
BLA |
BLA103914 |
Bamboo US BidCo LLC |
INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) |
15 ug/.5mL; 15 ug/.5mL; 15 ug/.5mL; 15 ug/.5mL |
10 SYRINGE, GLASS in 1 PACKAGE (83703-044-50) / .5 mL in 1 SYRINGE, GLASS (83703-044-88) |
| 83703-061-50 |
83703-061 |
VACCINE |
FLUZONE TRIVALENT |
INFLUENZA A VIRUS A/Victoria/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/California/122/2022 SAN-022 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
INJECTION, SUSPENSION |
INTRAMUSCULAR |
20240701 |
N/A |
BLA |
BLA103914 |
Bamboo US BidCo LLC |
INFLUENZA A VIRUS A/CALIFORNIA/122/2022 SAN-022 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) |
15 mg/.5mL; 15 mg/.5mL; 15 mg/.5mL |
10 SYRINGE, GLASS in 1 PACKAGE (83703-061-50) / .5 mL in 1 SYRINGE, GLASS (83703-061-88) |