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Immunization Action Coalition

Food and Drug Administration

FDA Product Approval: Vaccine index
View all HPV Pneumococcal - PPSV Td
Anthrax Influenza Polio - IPV Tdap
Chickenpox (varicella) Japanese encephalitis Rabies Typhoid
DTaP Measles Rotavirus Yellow fever
Hib Meningococcal Rubella
Hepatitis A Mumps Shingles (zoster)
Hepatitis B Pneumococcal - PCV Smallpox

Product Approval - Anthrax
BioThrax Product Approval
BioThrax Package Insert
Emergent BioSolutions
 
 
     

Product Approval - Chickenpox (varicella)
ProQuad Product Approval
ProQuad Package Insert
Merck & Co., Inc.
 
Varivax Product Approval
Varivax Package Insert
Merck & Co., Inc.
     

Product Approval - DTaP
DAPTACEL Product Approval
DAPTACEL Package Insert
sanofi pasteur
 
Pediarix Product Approval
Pediarix Package Insert
GlaxoSmithKline
     
Infanrix Product Approval
Infanrix Package Insert
GlaxoSmithKline
 
Pentacel Product Approval
Pentacel Package Insert
sanofi pasteur
     
KINRIX Product Approval
KINRIX Package Insert
GlaxoSmithKline
 
Tripedia Product Approval
Tripedia Package Insert [product discontinued]
sanofi pasteur
     

Product Approval - Haemophilus influenzae type b

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ActHIB Product Approval
ActHIB Package Insert
sanofi pasteur
 
Menhibrix Product Approval
Menhibrix Package Insert
GlaxoSmithKline
     
Comvax Product Approval
Comvax Package Insert
Merck & Co., Inc.
 
PedvaxHIB Product Approval
PedvaxHIB Package Insert
Merck & Co., Inc.
     
Hiberix® Product Approval
Hiberix Package Insert
GlaxoSmithKline
 
Pentacel Product Approval
Pentacel Package Insert
sanofi pasteur
     

Product Approval - Hepatitis A
Havrix Product Approval
Havrix Package Insert
GlaxoSmithKline
 
VAQTA Product Approval
VAQTA Package Insert
Merck & Co., Inc.
     
Twinrix Product Approval
Twinrix Package Insert
GlaxoSmithKline
   
     

Product Approval - Hepatitis B

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Comvax Product Approval
Comvax Package Insert
Merck & Co., Inc.
 
Recombivax HB Product Approval
Recombivax HB Package Insert
Merck & Co., Inc.
     
Engerix-B Product Approval
Engerix-B Package Insert
GlaxoSmithKline
 
Twinrix Product Approval
Twinrix Package Insert
GlaxoSmithKline
     
Pediarix Product Approval
Pediarix Package Insert
GlaxoSmithKline
   
     

Product Approval - Human papillomavirus (HPV)
Cervarix Product Approval
Cervarix Package Insert
GlaxoSmithKline
 
Gardasil Product Approval
Gardasil Package Insert
Merck & Co., Inc.
     

Product Approval - Influenza

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Afluria Product Approval (injectable)
Afluria Package Insert
CSL Biotherapies Inc.
 
FluMist (Quadrivalent) Product Approval (intranasal)
FluMist (Quadrivalent) Package Insert
MedImmune, Inc.
     
Fluarix Product Approval (injectable)
Fluarix Package Insert
GlaxoSmithKline
 
FluMist Product Approval (intranasal)
FluMist Package Insert
MedImmune, Inc.
     
Fluarix Quadrivalent Product Approval (injectable)
Fluarix Quadrivalent Package Insert
GlaxoSmithKline
 
Fluvirin Product Approval (injectable)
Fluvirin Package Insert
Novartis Vaccines
     
Flublok Quadrivalent Product Approval (injectable)
Flublok Package Insert
Protein Sciences Corporation
 
Fluzone Product Approval (injectable)
Fluzone Package Insert
sanofi pasteur
     
Flucelvax Product Approval
Flucelvax Package Insert
Novartis
 
Fluzone High-Dose Product Approval (injectable)
Fluzone Package Insert
sanofi pasteur
     
FluLaval Product Approval (injectable)
FluLaval Package Insert
GlaxoSmithKline
 
Fluzone Intradermal Product Approval (injectable)
Fluzone Package Insert
sanofi pasteur
     

Product Approval - Japanese encephalitis
IXIARO Product Approval
IXIARO Package Insert
Intercell Biomedical
 
 
 
 
     

Product Approval - Measles
ProQuad Product Approval
ProQuad Package Insert
Merck & Co., Inc.
 
MMR II Product Approval
MMR II Package Insert
Merck & Co., Inc.
     

Product Approval - Meningococcal

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Menactra Product Approval
Menactra Package Insert
sanofi pasteur
 
Menomune A/C/Y/W-135 Product Approval
Menomune A/C/Y/W-135 Package Insert
sanofi pasteur
     
Menhibrix Product Approval
Menhibrix Package Insert
GlaxoSmithKline
 
Menveo Product Approval
Menveo Package Insert
Novartis
     

Product Approval - Pneumococcal (PCV)
Prevnar 13 Product Approval
Prevnar Package Insert
Pfizer
   
     

Product Approval - Pneumococcal (PPSV)
Pneumovax 23 Product Approval
Pneumovax 23 Package Insert
Merck & Co., Inc.
   
     

Product Approval - Polio (IPV)
IPOL Product Approval
IPOL Package Insert
sanofi pasteur
 
Pediarix Product Approval
Pediarix Package Insert
GlaxoSmithKline
     
KINRIX Product Approval
KINRIX Package Insert
GlaxoSmithKline
 
Pentacel Product Approval
Pentacel Package Insert
sanofi pasteur
     

Product Approval - Rabies

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Imovax Product Approval
Imovax Package Insert
sanofi pasteur
 
RabAvert Product Approval
RabAvert Package Insert
Novartis
     

Product Approval - Rotavirus
Rotarix Product Approval
Rotarix Package Insert
GlaxoSmithKline
 
RotaTeq Product Approval
RotaTeq Package Insert
Merck & Co., Inc.
     

Product Approval - Rubella
MMR II Product Approval
MMR II Package Insert
Merck & Co., Inc.
 
 
 
 
     

Product Approval - Shingles (zoster)
Zostavax Product Approval
Zostavax Package Insert
Merck & Co., Inc.
   
     

Product Approval - Smallpox
ACAM2000 Product Approval
ACAM2000 Package Insert
sanofi pasteur
   
     

Product Approval - Tetanus (Td)

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DECAVAC Product Approval
DECAVAC Package Insert
sanofi pasteur
 
TENIVAC Product Approval
TENIVAC Package Insert
sanofi pasteur
     

Product Approval - Tetanus (Tdap)
Adacel Product Approval
Adacel Package Insert
sanofi pasteur
 
Boostrix Product Approval
Boostrix Package Insert
GlaxoSmithKline
     

Product Approval - Typhoid
TYPHIM Vi Product Approval
TYPHIM Vi Package Insert
sanofi pasteur
 
Vivotif Product Approval
Vivotif Package Insert
Berna
     

Product Approval - Yellow Fever

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YF-Vax Product Approval
YF-Vax Package Insert
sanofi pasteur
   
   
This page was reviewed on March 7, 2013
Immunization Action Coalition  •  1573 Selby Ave  •  St. Paul, MN 55104
tel 651-647-9009  •  fax 651-647-9131
 
This website is supported in part by a cooperative agreement from the National Center for Immunization and Respiratory Diseases (Grant No. 5U38IP000290) at the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. The website content is the sole responsibility of IAC and does not necessarily represent the official views of CDC.