Food and Drug Administration
FDA Product Approval: Vaccine index
View all HPV Pneumococcal - PCV Smallpox
Anthrax Influenza - H1N1 Pneumococcal - PPSV Td
Chickenpox (varicella) Influenza (seasonal) Polio - IPV Tdap
DTaP Japanese encephalitis Rabies Typhoid
Hib Measles Rotavirus Yellow fever
Hepatitis A Meningococcal Rubella
Hepatitis B Mumps Shingles (zoster)
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
sanofi pasteur
     
Product Approval - Haemophilus influenzae type b Back to top
ActHIB® Product Approval
ActHIB Package Insert
sanofi pasteur
 
HibTITER® Product Approval
HibTITER Package Insert
Pfizer
     
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 Back to top
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 (H1N1)
H1N1 Vaccine Product Approval (injectable)
H1N1 Package Insert
CSL Biotherapies, Inc.
 
H1N1 Vaccine Product Approval (injectable)
H1N1 Package Insert
Novartis Vaccines
     
H1N1 Vaccine Product Approval (injectable)
H1N1 Package Insert
GlaxoSmithKline
 
H1N1 Vaccine Product Approval (intranasal)
H1N1 Package Insert
MedImmune, Inc
     
H1N1 Vaccine, Product Approval (injectable)
H1N1 Package Insert
sanofi pasteur
   
     
Product Approval - Influenza (seasonal) Back to top
Afluria® Product Approval (injectable)
Afluria Package Insert
CSL Biotherapies Inc.
 
Fluvirin® Product Approval (injectable)
Fluvirin Package Insert
Novartis Vaccines
     
Agriflu Product Approval (injectable)
Agriflu Package Insert
Novartis
 
Fluzone® Product Approval (injectable)
Fluzone Package Insert

sanofi pasteur

     
Fluarix® Product Approval (injectable)
Fluarix Package Insert
GlaxoSmithKline
 
Fluzone High-Dose Product Approval (injectable)
Package Insert

sanofi pasteur

     
FluLaval® Product Approval (injectable)
FluLaval Package Insert
GlaxoSmithKline
 
FluMist® Product Approval (intranasal)
FluMist Package Insert
MedImmune, Inc
     
Product Approval - Japanese encephalitis
JE-Vax® Product Approval
JE-Vax Package Insert
sanofi pasteur
 
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 Back to top
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
     
Menveo 13 Product Approval
Menveo Package Insert
Novartis
 
 
 
 
     
Product Approval - Pneumococcal (PCV)
Prevnar® Product Approval
Prevnar Package Insert
Pfizer
 
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 Back to top
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
Acambis Inc.
   
     
Product Approval - Tetanus (Td) Back to top
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 Back to top
YF-Vax® Product Approval
YF-Vax Package Insert
sanofi pasteur
   
   
This page was reviewed on March 3, 2010
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