美国药品NDC(国家药品编码)与药品说明书数据库(U.S. FDA National Drug Code DataBase)
检索条件:" 注册申请号=BLA103914"
NDC包装代码 产品NDC 产品类型 商品名 通用名 剂型 给药途径 上市日期 结束日期 市场类别 申请号 标签持有者 活性成分 规格 包装描述
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)
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