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Immunization Action Coalition

Food and Drug Administration

FDA Product Approval: Vaccine index

Adenovirus Hepatitis B Pneumococcal - PCV Tdap
Anthrax HPV Pneumococcal - PPSV Typhoid
BCG Influenza Polio - IPV Varicella (chickenpox)
Cholera Japanese encephalitis Rabies Yellow fever
DT Measles Rotavirus Zoster (shingles)
DTaP Meningococcal ACWY Rubella  
Hib Meningococcal B Smallpox  
Hepatitis A Mumps Td

Product Approval - Adenovirus

Adenovirus Package Insert
Barr Labs Inc.
Adenovirus Product Approval 
 
 
     

Product Approval - Anthrax

BioThrax Package Insert
Emergent BioSolutions
BioThrax Product Approval 
 
 
     

Product Approval - BCG Vaccine (tuberculosis)

BCG Package Insert
Organon Teknica (Merck)
BCG Product Approval 
   
     

Product Approval - Cholera

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Vaxchora Package Insert
PaxVax
Vaxchora Product Approval 
   
     

Product Approval - DT

DT (generic) Package Insert
Sanofi Pasteur
DT (generic) Product Approval 
   
     

Product Approval - DTaP

Daptacel Package Insert
Sanofi Pasteur
Daptacel Product Approval 
 
Pediarix Package Insert
GlaxoSmithKline
Pediarix Product Approval 
     
Infanrix Package Insert
GlaxoSmithKline
Infanrix Product Approval 
 
Pentacel Package Insert
Sanofi Pasteur
Pentacel Product Approval 
     
Kinrix Package Insert
GlaxoSmithKline
Kinrix Product Approval 
 
Quadracel Package Insert
Sanofi Pasteur
Quadracel Product Approval 
     

Product Approval - Haemophilus influenzae type b

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ActHIB Package Insert
Sanofi Pasteur
ActHIB Product Approval 
 
PedvaxHIB Package Insert
Merck & Co., Inc.
PedvaxHIB Product Approval 
     
Hiberix Package Insert
GlaxoSmithKline
Hiberix Product Approval 
 
Pentacel Package Insert
Sanofi Pasteur
Pentacel Product Approval 
     
Menhibrix Package Insert
GlaxoSmithKline
Menhibrix Product Approval 
   
     

Product Approval - Hepatitis A

Havrix Package Insert
GlaxoSmithKline
Havrix Product Approval 
 
Vaqta Package Insert
Merck & Co., Inc.
Vaqta Product Approval 
     
Twinrix Package Insert
GlaxoSmithKline
Twinrix Product Approval 
   
     

Product Approval - Hepatitis B

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

Product Approval - Human papillomavirus (HPV)

Gardasil Package Insert
Merck & Co., Inc.
Gardasil Product Approval 
 
Gardasil 9 Package Insert
Merck & Co., Inc.
Gardasil 9 Product Approval 
     

Product Approval - Influenza

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Afluria Package Insert
Seqirus
Afluria Product Approval (injectable) 
 
FluLaval Quadrivalent Package Insert
GlaxoSmilthKline
FluLaval Quadrivalent Product Approval (injectable) 
     
Afluria Quadrivalent Package Insert
Seqirus
Afluria Quadrivalent Product Approval (injectable) 
 
FluMist Quadrivalent Package Insert
MedImmune, Inc.
FluMist Quadrivalent Product Approval (intranasal) 
     
Fluad Package Insert
Seqirus
Fluad Product Approval (injectable) 
 
Fluvirin Package Insert
Seqirus (Novartis)
Fluvirin Product Approval (injectable) 
     
Fluarix Quadrivalent Package Insert
GlaxoSmithKline
Fluarix Quadrivalent Product Approval (injectable) 
 
Fluzone High-Dose Package Insert
Sanofi Pasteur
Fluzone High-Dose Product Approval (injectable) 
     
Flublok Package Insert
Protein Sciences Corporation
Flublok Product Approval (injectable) 
 
Fluzone Intradermal Package Insert
Sanofi Pasteur
Fluzone Intradermal Product Approval (injectable) 
     
Flublok Quadrivalent Package Insert
Protein Sciences Corporation
Flublok Quadrivalent Product Approval 
 
Fluzone Quadrivalent Package Insert
Sanofi Pasteur
Fluzone Quadrivalent Product Approval (injectable) 
     
Flucelvax Quadrivalent Package Insert
Seqirus
Flucelvax Quadrivalent Product Approval (injectable) 
   
     

Product Approval - Japanese encephalitis

IXIARO Package Insert
Valneva
IXIARO Product Approval 
 
 
 
 
     

Product Approval - Measles

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

Product Approval - Meningococcal ACWY

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Menactra Package Insert
Sanofi Pasteur
Menactra Product Approval 
 
Menomune A/C/Y/W-135 Package Insert
Sanofi Pasteur
Menomune A/C/Y/W-135 Product Approval 
     
Menhibrix Package Insert
GlaxoSmithKline
Menhibrix Product Approval 
 
Menveo Package Insert
Glaxo Smith Kline
Menveo Product Approval 
     

Product Approval - Meningococcal B

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Bexsero Package Insert
GlaxoSmithKline
Bexsero Product Approval 
 
Trumenba Package Insert
Pfizer
Trumenba Product Approval 
     

Product Approval - Mumps

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MMR II Package Insert
Merck & Co.
MMR II Product Approval 
 
ProQuad Package Insert
Merck & Co.
ProQuad Product Approval 
     

Product Approval - Pneumococcal (PCV)

Prevnar Package Insert
Pfizer
Prevnar 13 Product Approval 
   
     

Product Approval - Pneumococcal (PPSV)

Pneumovax 23 Package Insert
Merck & Co., Inc.
Pneumovax 23 Product Approval 
   
     

Product Approval - Polio (IPV)

IPOL Package Insert
Sanofi Pasteur
IPOL Product Approval 
 
Pentacel Package Insert
Sanofi Pasteur
Pentacel Product Approval 
     
Kinrix Package Insert
GlaxoSmithKline
Kinrix Product Approval 
 
Quadracel Package Insert
Sanofi Pasteur
Quadracel Product Approval 
     
Pediarix Package Insert
GlaxoSmithKline
Pediarix Product Approval 
   
     

Product Approval - Rabies

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Imovax Package Insert
Sanofi Pasteur
Imovax Product Approval 
 
RabAvert Package Insert
Glaxo Smith Kline
RabAvert Product Approval 
     

Product Approval - Rotavirus

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

Product Approval - Rubella

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

Product Approval - Smallpox

ACAM2000 Package Insert
Sanofi Pasteur
ACAM2000 Product Approval 
   
     

Product Approval - Tetanus (Td)

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Td (generic) Package Insert
Mass. Biological Lab
Td (generic) Product Approval 
 
Tenivac Package Insert
Sanofi Pasteur
Tenivac Product Approval 
     

Product Approval - Tetanus (Tdap)

Adacel Package Insert
Sanofi Pasteur
Adacel Product Approval 
 
Boostrix Package Insert
GlaxoSmithKline
Boostrix Product Approval 
     

Product Approval - Typhoid

Typhim Vi Package Insert
Sanofi Pasteur
Typhim Vi Product Approval 
 
Vivotif Package Insert
PaxVax
Vivotif Product Approval 
     

Product Approval - Varicella (chickenpox)

Varivax Package Insert
Merck & Co., Inc.
Varivax Product Approval 
 
ProQuad Package Insert
Merck & Co., Inc.
ProQuad Product Approval 
     

Product Approval - Yellow Fever

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YF-Vax Package Insert
Sanofi Pasteur
YF-Vax Product Approval 
   
     

Product Approval - Zoster (shingles)

Zostavax Package Insert
Merck & Co., Inc.
Zostavax Product Approval 
   
   
This page was updated on February 15, 2017.
This page was reviewed on February 15, 2017.
 
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