FDA 药品与器械查询
实时对接美国 FDA 官方开放数据（openFDA），可查询美国上市药品 NDC 目录、医疗器械管理类别与 21 CFR 法规号、以及已获许可的 510(k) 清单，用于出海美国的准入判断、注册路径选择与同类竞品调研。支持中文关键词自动转英文检索。
数据源：美国 FDA 官方开放数据平台 openFDA，实时查询美国上市药品 NDC 目录、器械分类与 510(k) 许可，用于出海美国的准入与合规自查。
支持中文关键词自动转英文检索；此为美国监管口径，与中国 NMPA 批准情况相互独立。
查询美国市场在售药品：剂型、给药途径、活性成分、持证商与 NDC 编码，用于判断目标品种在美国是否已有同类上市。
已将中文关键词转为英文「vaccine」检索 FDA 数据库。
共找到 107 条与「vaccine」匹配的结果
当前展示 50 条美国 FDA 上市药品记录； 海关数据库提供全球买卖明细与竞争对手出货记录咨询完整数据 ›
| 药品名称 | NDC 编码 | 剂型 | 给药途径 | 活性成分 | 持证商 | 上市类别 |
|---|---|---|---|---|---|---|
VARIVAX Varicella Virus Vaccine Live | 0006-4827 | INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION | SUBCUTANEOUS | VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN 1350 [PFU]/.5mL | Merck Sharp & Dohme LLC | BLA |
RECOMBIVAX HB Hepatitis B Vaccine (Recombinant) | 0006-4992 | INJECTION, SUSPENSION | INTRAMUSCULAR、SUBCUTANEOUS | HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 40 ug/mL | Merck Sharp & Dohme LLC | BLA |
RotaTeq Rotavirus Vaccine, Live, Oral, Pentavalent | 0006-4047 | SOLUTION | ORAL | HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN 2200000 [iU]/2mL；HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGEN 2800000 [iU]/2mL；HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGEN 2200000 [iU]/2mL；HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGEN 2000000 [iU]/2mL；HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGEN 2300000 [iU]/2mL | Merck Sharp & Dohme LLC | BLA |
Moderna COVID-19 Vaccine Moderna COVID-19 Vaccine | 84586-012 | INJECTION, SUSPENSION | — | CX-046684 25 ug/.25mL | Alloga Logstica Espaa S.L. | DRUG FOR FURTHER PROCESSING |
Respiratory Syncytial Virus Vaccine Respiratory Syncytial Virus Vaccine | 84586-112 | SUSPENSION | — | RNA-100-AR02 50 ug/.5mL | Alloga Logstica Espaa S.L. | DRUG FOR FURTHER PROCESSING |
PREVNAR 13 pneumococcal 13-valent conjugate vaccine | 50090-1944 | INJECTION, SUSPENSION | INTRAMUSCULAR | STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 4.4 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL | A-S Medication Solutions | BLA |
Comirnaty COVID-19 Vaccine, mRNA | 0069-2528 | INJECTION, SUSPENSION | INTRAMUSCULAR | BNT162B2 OMICRON (LP.8.1) .042 mg/.418mL | Pfizer Laboratories Div Pfizer Inc | BLA |
GARDASIL 9 Human Papillomavirus 9-valent Vaccine, Recombinant | 0006-4121 | INJECTION, SUSPENSION | INTRAMUSCULAR | HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN 30 ug/.5mL；HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN 40 ug/.5mL；HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN 60 ug/.5mL；HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN 40 ug/.5mL；HUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGEN 20 ug/.5mL；HUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN 20 ug/.5mL；HUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN 20 ug/.5mL；HUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN 20 ug/.5mL；HUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN 20 ug/.5mL | Merck Sharp & Dohme LLC | BLA |
IXIARO Japanese Encephalitis Vaccine, Inactivated, Adsorbed | 42515-002 | INJECTION, SUSPENSION | INTRAMUSCULAR | JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED) 6 [arb'U]/.5mL | Valneva Scotland Ltd. | BLA |
Prevnar 20 Pneumococcal 20-valent Conjugate Vaccine | 0005-2000 | INJECTION, SUSPENSION | INTRAMUSCULAR | STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 4.4 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2.2 ug/.5mL | Wyeth Pharmaceutical Division of Wyeth Holdings LLC | BLA |
RotaTeq Rotavirus Vaccine, Live, Oral, Pentavalent | 0006-4379 | SOLUTION | ORAL | HUMAN ROTAVIRUS A TYPE G1P7(5) STRAIN WI79 LIVE ANTIGEN 2200000 [iU]/2mL；HUMAN ROTAVIRUS A TYPE G2P7(5) STRAIN SC2 LIVE ANTIGEN 2800000 [iU]/2mL；HUMAN ROTAVIRUS A TYPE G3P7(5) STRAIN WI78 LIVE ANTIGEN 2200000 [iU]/2mL；HUMAN ROTAVIRUS A TYPE G4P7(5) STRAIN BRB LIVE ANTIGEN 2000000 [iU]/2mL；HUMAN ROTAVIRUS A TYPE G6P1A(8) STRAIN WI79 LIVE ANTIGEN 2300000 [iU]/2mL | Merck Sharp & Dohme LLC | BLA |
PNEUMOVAX 23 pneumococcal vaccine polyvalent | 0006-4943 | INJECTION, SOLUTION | INTRAMUSCULAR、SUBCUTANEOUS | STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN 25 ug/.5mL | Merck Sharp & Dohme LLC | BLA |
Comirnaty COVID-19 Vaccine, mRNA | 0069-2501 | INJECTION, SUSPENSION | INTRAMUSCULAR | BNT162B2 OMICRON (LP.8.1) .0158 mg/.48mL | Pfizer Laboratories Div Pfizer Inc | BLA |
FLUARIX 2026/2027 influenza virus vaccine | 58160-725 | SUSPENSION | INTRAMUSCULAR | INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug/.5mL；INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug/.5mL；INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED) 15 ug/.5mL | GlaxoSmithKline Biologicals SA | BLA |
Ixiaro Japanese Encephalitis Vaccine, Inactivated, Adsorbed | 62195-051 | INJECTION, SUSPENSION | INTRAMUSCULAR | JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED) 6 ug/.5mL | Vetter Pharma Fertigung GmbH & Co. KG | BLA |
Hiberix Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) | 58160-726 | KIT | — | — | GlaxoSmithKline Biologicals SA | BLA |
Rotarix Rotavirus Vaccine, Live, Oral | 58160-740 | SOLUTION | ORAL | HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN 1000 [CCID_50]/mL | GlaxoSmithKline Biologicals SA | BLA |
BCG VACCINE BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN | 0052-0603 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | PERCUTANEOUS | BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN 50 mg/1 | Merck Sharp & Dohme LLC | BLA |
Arepanrix Influenza A H5 Monovalent Vaccine | 58160-742 | KIT | — | — | GlaxoSmithKline Biologicals SA | BLA |
INFANRIX Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed | 58160-810 | SUSPENSION | INTRAMUSCULAR | CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 10 [iU]/.5mL；CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 25 [iU]/.5mL；BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) 25 ug/.5mL；BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 25 ug/.5mL；BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) 8 ug/.5mL | GlaxoSmithKline Biologicals SA | BLA |
Respiratory Syncytial Virus Vaccine Respiratory Syncytial Virus Vaccine | 68263-003 | SUSPENSION | — | RNA-100-AR02 50 ug/.5mL | ROVI Pharma Industrial Services S.A. | DRUG FOR FURTHER PROCESSING |
GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant | 0006-4109 | INJECTION, SUSPENSION | INTRAMUSCULAR | HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN 20 ug/.5mL；HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN 40 ug/.5mL；HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN 40 ug/.5mL；HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN 20 ug/.5mL | Merck Sharp & Dohme LLC | BLA |
PEDIARIX Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined | 58160-811 | INJECTION, SUSPENSION | INTRAMUSCULAR | CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 25 [iU]/.5mL；CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 10 [iU]/.5mL；BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) 25 ug/.5mL；BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 25 ug/.5mL；BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) 8 ug/.5mL；HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 10 ug/.5mL；POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) 40 [iU]/.5mL；POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) 8 [iU]/.5mL；POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) 32 [iU]/.5mL | GlaxoSmithKline Biologicals SA | BLA |
Moderna COVID-19 Vaccine Moderna COVID-19 Vaccine | 68263-012 | INJECTION, SUSPENSION | — | CX-046684 25 ug/.25mL | ROVI Pharma Industrial Services S.A. | DRUG FOR FURTHER PROCESSING |
KINRIX Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine | 58160-812 | INJECTION, SUSPENSION | INTRAMUSCULAR | CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 25 [iU]/.5mL；CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 10 [iU]/.5mL；BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 25 [iU]/.5mL；BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) 8 ug/.5mL；BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) 25 ug/.5mL；POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) 40 [iU]/.5mL；POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) 8 [iU]/.5mL；POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) 32 [iU]/.5mL | GlaxoSmithKline Biologicals SA | BLA |
TWINRIX Hepatitis A and Hepatitis B (Recombinant) Vaccine | 58160-815 | INJECTION, SUSPENSION | INTRAMUSCULAR | HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) 720 [iU]/mL；HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 20 ug/mL | GlaxoSmithKline Biologicals SA | BLA |
Hiberix Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) | 58160-818 | KIT | — | — | GlaxoSmithKline Biologicals SA | BLA |
ENGERIX-B Hepatitis B Vaccine (Recombinant) | 58160-820 | INJECTION, SUSPENSION | INTRAMUSCULAR | HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 10 ug/.5mL | GlaxoSmithKline Biologicals SA | BLA |
ENGERIX-B Hepatitis B Vaccine (Recombinant) | 58160-821 | INJECTION, SUSPENSION | INTRAMUSCULAR | HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 20 ug/mL | GlaxoSmithKline Biologicals SA | BLA |
Shingrix Zoster Vaccine Recombinant, Adjuvanted | 58160-823 | KIT | — | — | GlaxoSmithKline Biologicals SA | BLA |
Priorix Measels, Mumps, and Rubella Vaccine, Live | 58160-824 | KIT | — | — | GlaxoSmithKline Biologicals SA | BLA |
VAXNEUVANCE Pneumococcal 15-valent Conjugate Vaccine CRM197 Protein adsorbed | 0006-4329 | INJECTION, SUSPENSION | INTRAMUSCULAR | STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 4 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug/.5mL；STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 2 ug/.5mL；CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN 30 ug/.5mL | Merck Sharp & Dohme LLC | BLA |
HAVRIX Hepatitis A Vaccine | 58160-825 | INJECTION, SUSPENSION | INTRAMUSCULAR | HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) 720 [iU]/.5mL | GlaxoSmithKline Biologicals SA | BLA |
HAVRIX Hepatitis A Vaccine | 58160-826 | INJECTION, SUSPENSION | INTRAMUSCULAR | HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) 1440 [iU]/mL | GlaxoSmithKline Biologicals SA | BLA |
Menveo Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine | 58160-827 | INJECTION, SOLUTION | INTRAMUSCULAR | NEISSERIA MENINGITIDIS GROUP A CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 10 ug/.5mL；NEISSERIA MENINGITIDIS GROUP C CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 5 ug/.5mL；NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 5 ug/.5mL；NEISSERIA MENINGITIDIS GROUP Y CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 5 ug/.5mL | GlaxoSmithKline Biologicals SA | BLA |
BOOSTRIX Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed | 58160-842 | SUSPENSION | INTRAMUSCULAR | CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5 [iU]/.5mL；CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 2.5 [iU]/.5mL；BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) 8 ug/.5mL；BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 8 ug/.5mL；BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) 2.5 ug/.5mL | GlaxoSmithKline Biologicals SA | BLA |
Arexvy Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted | 58160-848 | KIT | — | — | GlaxoSmithKline Biologicals SA | BLA |
Shingrix Zoster Vaccine Recombinant, Adjuvanted | 58160-849 | INJECTION, SOLUTION | INTRAMUSCULAR | RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN 50 ug/.5mL | GlaxoSmithKline Biologicals SA | BLA |
TicoVac Tick-Borne Encephalitis Vaccine | 0069-0411 | INJECTION | INTRAMUSCULAR | TICK-BORNE ENCEPHALITIS PURIFIED ANTIGEN (FORMALDEHYDE INACTIVATED) 2.4 ug/.5mL | Pfizer Laboratories Div Pfizer Inc | BLA |
Arexvy Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted | 58160-882 | KIT | — | — | GlaxoSmithKline Biologicals SA | BLA |
Arexvy Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted | 58160-894 | KIT | — | — | GlaxoSmithKline Biologicals SA | BLA |
VAQTA hepatitis A vaccine, inactivated | 0006-4841 | INJECTION, SUSPENSION | INTRAMUSCULAR | HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) 50 [iU]/mL | Merck Sharp & Dohme LLC | BLA |
Menveo Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine | 58160-955 | KIT | — | — | GlaxoSmithKline Biologicals SA | BLA |
FluMist Influenza Vaccine Live Intranasal | 66019-113 | SPRAY | NASAL | INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 (H1N1) LIVE (ATTENUATED) ANTIGEN 10000000 [FFU]/.2mL；INFLUENZA A VIRUS A/DARWIN/1369/2025 (H3N2) LIVE (ATTENUATED) ANTIGEN 10000000 [FFU]/.2mL；INFLUENZA B VIRUS B/PERTH/115/2025 LIVE (ATTENUATED) ANTIGEN 10000000 [FFU]/.2mL | MedImmune, LLC | BLA |
Influenza Vaccine Live Intranasal Influenza Vaccine Live Intranasal | 66020-051 | SPRAY | — | INFLUENZA B VIRUS 1000000 [FFU]/125mL；INFLUENZA A VIRUS 1000000 [FFU]/125mL | MedImmune, U.K. Limited | DRUG FOR FURTHER PROCESSING |
VAQTA hepatitis A vaccine, inactivated | 0006-4095 | INJECTION, SUSPENSION | INTRAMUSCULAR | HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) 25 [iU]/.5mL | Merck Sharp & Dohme LLC | BLA |
Moderna COVID-19 Vaccine Moderna COVID-19 Vaccine | 50024-300 | INJECTION, SUSPENSION | — | CX-046684 25 ug/.25mL | ROVI Pharma Industrial Services S.A. | DRUG FOR FURTHER PROCESSING |
Respiratory Syncytial Virus Vaccine Respiratory Syncytial Virus Vaccine | 50024-311 | SUSPENSION | — | RNA-100-AR02 50 ug/.5mL | ROVI Pharma Industrial Services S.A. | DRUG FOR FURTHER PROCESSING |
VAQTA hepatitis A vaccine, inactivated | 0006-4831 | INJECTION, SUSPENSION | INTRAMUSCULAR | HEPATITIS A VIRUS STRAIN CR 326F ANTIGEN (FORMALDEHYDE INACTIVATED) 25 [iU]/.5mL | Merck Sharp & Dohme LLC | BLA |
ENGERIX-B Hepatitis B Vaccine (Recombinant) | 50090-1223 | INJECTION, SUSPENSION | INTRAMUSCULAR | HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 20 ug/mL | A-S Medication Solutions | BLA |
数据随 FDA 官方库更新，仅供参考，不构成医学或法律建议；正式注册与报关请以 FDA 官方文件及最新法规为准。