Home
|
About IAC
|
Contact
|
A-Z Index
|
Donate
|
Shop
|
SUBSCRIBE
Immunization Action Coalition

Food and Drug Administration

FDA Product Approval: Vaccine index

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

Product Approval - Adenovirus

Product Approval Adenovirus
Adenovirus Package Insert
Barr Labs Inc.
 
 
     

Product Approval - Anthrax

BioThrax Product Approval
BioThrax Package Insert
Emergent BioSolutions
 
 
     

Product Approval - DTaP

Daptacel Product Approval
Daptacel Package Insert
Sanofi Pasteur
 
Pediarix Product Approval
Pediarix Package Insert
GlaxoSmithKline
     
DT (generic) Product Approval
DT Package Insert
Sanofi Pasteur
 
Pentacel Product Approval
Pentacel Package Insert
Sanofi Pasteur
     
Infanrix Product Approval
Infanrix Package Insert
GlaxoSmithKline
 
Quadracel Product Approval
Quadracel Package Insert
Sanofi Pasteur
     
Kinrix Product Approval
Kinrix Package Insert
GlaxoSmithKline
   
     

Product Approval - Haemophilus influenzae type b

Back to top
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

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

Product Approval - Influenza

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

Product Approval - Japanese encephalitis

IXIARO Product Approval
IXIARO Package Insert
Intercell Biomedical
 
 
 
 
     

Product Approval - Measles

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

Product Approval - Meningococcal ACWY

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
     
Menhibrix Product Approval
Menhibrix Package Insert
GlaxoSmithKline
 
Menveo Product Approval
Menveo Package Insert
Glaxo Smith Kline
     

Product Approval - Meningococcal B

Back to top
Bexsero Product Approval
Bexsero Package Insert
Novartis
 
Trumenba Product Approval
Trumenba Package Insert
Pfizer
     

Product Approval - Mumps

Back to top
MMR II Product Approval
MMR II Package Insert
Merck & Co.
 
ProQuad Product Approval
ProQuad Package Insert
Merck & Co.
     

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

Product Approval - Rabies

Back to top
Imovax Product Approval
Imovax Package Insert
Sanofi Pasteur
 
RabAvert Product Approval
RabAvert Package Insert
Glaxo Smith Kline
     

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

Product Approval - Smallpox

ACAM2000 Product Approval
ACAM2000 Package Insert
Sanofi Pasteur
   
     

Product Approval - Tetanus (Td)

Back to top
Td (generic) Product Approval
Package insert link
Mass. Biological Lab
 
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
Crucell (PaxVax)
     

Product Approval - Varicella (chickenpox)

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

Product Approval - Yellow Fever

Back to top
YF-Vax Product Approval
YF-Vax Package Insert
Sanofi Pasteur
   
     

Product Approval - Zoster (shingles)

Zostavax Product Approval
Zostavax Package Insert
Merck & Co., Inc.
   
   
This page was updated on March 30, 2016.
This page was reviewed on March 30, 2016.
Immunization Action Coalition  •  2550 University Avenue West  •  Suite 415 North  •  Saint Paul, Minnesota  •  55114
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. 5U38IP000589) 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.