Vaccines, Blood & Biologics
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Vaccines Licensed for Immunization and Distribution in the US with Supporting Documents
This list includes only vaccines for which supporting documents were provided and is arranged alphabetically by the proper name of the product. Information is provided for original product approvals, new indications, and the current package insert. For a complete list of approved vaccines, click the link under "Related Information" at the bottom of this page.
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Vaccines with Supporting Documents
Adenovirus Type 4 and Type 7 Vaccine, Live, Oral Barr Labs, Inc. Anthrax Vaccine Adsorbed Emergent BioDefense Operations Lansing, Inc. (Biothrax) BCG Live Organon Teknika Corp (TICE BCG, BCG Vaccine) Diphtheria & Tetanus Toxoids Adsorbed Sanofi Pasteur, Inc Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed Sanofi Pasteur, Inc (Tripedia); GlaxoSmithKline Biologicals (Infanrix); Sanofi Pasteur, Ltd (Daptacel) Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined GlaxoSmithKline Biologicals (Pediarix) Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine GlaxoSmithKline Biologicals (Kinrix) Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Sanofi Pasteur, Ltd (Pentacel) Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) Sanofi Pasteur, SA (ActHIB); GlaxoSmithKline Biologicals, S.A., (Hiberix) Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate) Merck Sharp & Dohme Corp. (PedvaxHIB) Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine Merck & Co, Inc (Comvax) Hepatitis A Vaccine, Inactivated GlaxoSmithKline Biologicals (Havrix); Merck & Co, Inc (Vaqta) Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine GlaxoSmithKline Biologicals (Twinrix) Hepatitis B Vaccine (Recombinant) Merck & Co, Inc (Recombivax HB); GlaxoSmithKline Biologicals (Engerix-B) Human Papillomavirus Vaccine Merck & Co, Inc (Gardasil), GlaxoSmithKline Biologicals (Cervarix) Influenza A (H1N1) 2009 Monovalent CSL Limited; MedImmune LLC; ID Biomedical Corporation of Quebec; Novartis Vaccines and Diagnostics Limited; Sanofi Pasteur, Inc. Influenza Virus Vaccine, H5N1 (for National Stockpile) Sanofi Pasteur, Inc Influenza Virus Vaccine, Quadrivalent, Types A and Types B MedImmune, LLC (FluMist Quadrivalent) Influenza Virus Vaccine, Trivalent, Types A and B CSL Limited (Afluria); ID Biomedical Corp of Quebec (FluLaval); GlaxoSmithKline Biologicals (Fluarix); Novartis Vaccines and Diagnostics, Ltd (Fluvirin); Novartis Vaccines and Diagnostics Inc. (Agriflu); Sanofi Pasteur, Inc (Fluzone); MedImmune, LLC... Japanese Encephalitis Vaccine, Inactivated, Adsorbed Intercell Biomedical (Ixiaro) Japanese Encephalitis Virus Vaccine Inactivated Research Foundation for Microbial Diseases of Osaka University (JE-Vax) Measles Virus Vaccine, Live Merck & Co, Inc (Attenuvax) Measles, Mumps and Rubella Virus Vaccine, Live Merck & Co, Inc (M-M-R II) Measles, Mumps, Rubella and Varicella Virus Vaccine Live Merck & Co, Inc (ProQuad) Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine Novartis Vaccines and Diagnostics, Inc. (Menveo) MenHibrix GlaxoSmithKline Biologicals (MenHibrix) Meningococcal Groups (A, C, Y and W-135) Polysaccharide Diptheria Toxoid Conjugate Vaccine Sanofi Pasteur, Inc (Menactra) Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined Sanofi Pasteur, Inc (Menomune-A/C/Y/W-135) Pneumococcal Vaccine, Polyvalent Merck & Co, Inc (Pneumovax 23) Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Wyeth Pharmaceuticals, Inc (Prevnar) Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Wyeth Pharmaceuticals, Inc (Prevnar 13) Poliovirus Vaccine Inactivated (Monkey Kidney Cell) Sanofi Pasteur, SA (IPOL) Rabies Vaccine Sanofi Pasteur, SA (Imovax); Novartis Vaccines and Diagnostics, Ltd (RabAvert) Rotavirus Vaccine, Live, Oral GlaxoSmithKline Pharmaceuticals (Rotarix) Rotavirus Vaccine, Live, Oral, Pentavalent Merck & Co, Inc (RotaTeq) Rubella Virus Vaccine Live Merck & Co, Inc (Meruvax II) Smallpox (Vaccinia) Vaccine, Live Sanofi Pasteur Biologics Co (ACAM2000) Tetanus & Diphtheria Toxoids, Adsorbed Massachusetts Public Health Biologic Lab (No Trade Name) Tetanus & Diphtheria Toxoids Adsorbed for Adult Use Sanofi Pasteur, Inc. (Decavac); Sanofi Pasteur, Ltd. (Tenivac) Tetanus Toxoid Sanofi Pasteur, Inc Tetanus Toxoid Adsorbed Sanofi Pasteur, Inc Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed Sanofi Pasteur, Ltd (Adacel); GlaxoSmithKline Biologicals (Boostrix) Typhoid Vaccine Live Oral Ty21a Berna Biotech, Ltd (Vivotif) Typhoid Vi Polysaccharide Vaccine Sanofi Pasteur SA (Typhim Vi) Varicella Virus Vaccine, Live Merck & Co, Inc (Varivax) Yellow Fever Vaccine Sanofi Pasteur, Inc (YF-Vax) Zoster Vaccine, Live Merck & Co, Inc (Zostavax)
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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