Vaccine Policy and Licensure
Package inserts and information from the Food and Drug Administration
Vaccine index Resources
Anthrax
Influenza
Rabies
Varicella
DTaP
Japanese encephalitis
Rotavirus
Yellow fever
Hib
MMR
Smallpox
Zoster
Hepatitis A
Meningococcal
Td
Hepatitis B
Pneumococcal
Tdap
HPV
Polio
Typhoid
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FDA Licensure - Anthrax back to top
Package insert:
Manufacturer/Distributor
BioThrax
Additional FDA information
Contact/order: (800) 533-5899
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FDA Licensure - DTaP back to top
Package insert:
Manufacturer/Distributor
DAPTACEL
Additional FDA information
Contact/order: (800) 822-2463
Package insert:
Manufacturer/Distributor
Tripedia
Additional FDA information
Contact/order: (800) 822-2463
Package insert:
Manufacturer/Distributor
Infanrix
Additional FDA information
Contact/order: (866) 475-8222
Package insert: DTaP+Hib
Manufacturer/Distributor
TriHIBit combination vaccine see:
Tripedia & ActHIB 
Contact/order: (800) 822-2463
Package insert: DTaP+HepB+IPV
Manufacturer/Distributor
Pediarix
Additional FDA information
Contact/order: (800) 822-2463
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FDA Licensure - Haemophilus influenzae type b (Hib) back to top
Package insert:
Manufacturer/Distributor
ActHIB
Additional FDA information
Contact/order: (800) 822-2463
Package insert:
Manufacturer/Distributor
HibTITER
Additional FDA information
Contact: (800) 999-9384
To order: (800) 582-8221
Package insert:
Manufacturer/Distributor
PedvaxHIB
Contact: (800) 672-6372
To order: (800) 637-2579
Package insert: Hib+HepB
Manufacturer/Distributor
Comvax
Additional FDA information
Contact: (800) 672-6372
To order: (800) 637-2579
Package insert: Hib+DTaP
Manufacturer/Distributor
TriHIBit combination vaccine see:
Tripedia & ActHIB 
Contact/order: (800) 822-2463
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FDA Licensure - Hepatitis A back to top
Package insert:
Manufacturer/Distributor
Havrix
Additional FDA information
Contact/order: (866) 475-8222
Package insert:
Manufacturer/Distributor
VAQTA
Additional FDA information
Contact: (800) 672-6372
To order: (800) 637-2579
Package insert: HepA+HepB
Manufacturer/Distributor
Twinrix
Additional FDA information
Contact/order: (866) 475-8222
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FDA Licensure - Hepatitis B back to top
Package insert:
Manufacturer/Distributor
Recombivax HB
Additional FDA information
Contact: (800) 672-6372
To order: (800) 637-2579
Package insert:
Manufacturer/Distributor
Engerix-B
Additional FDA information
Contact/order: (866) 475-8222
Package insert: HepB+Hib
Manufacturer/Distributor
Comvax
Additional FDA information
Contact: (800) 672-6372
To order: (800) 637-2579
Package insert: HepB+IPV+DTaP
Manufacturer/Distributor
Pediarix
Additional FDA information
Contact/order: (800) 822-2463
Package insert: HepB+HepA
Manufacturer/Distributor
Twinrix
Additional FDA information
Contact/order: (866) 475-8222
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FDA Licensure - HPV back to top
Package insert:
Manufacturer/Distributor
Gardasil
Additional FDA information
Contact: (800) 672-6372
To order: (800) 637-2579
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FDA Licensure - Influenza back to top
Package insert: Influenza (inactivated, injectable)
Manufacturer/Distributor
Afluria
Additional FDA information
Contact/order: (888) 435-8633
Package insert: Influenza (inactivated, injectable)
Manufacturer/Distributor
Fluarix
Additional FDA information
Contact/order: (866) 475-8222
Package insert: Influenza (inactivated, injectable)
Manufacturer/Distributor
Fluvirin
Additional FDA information
Contact/order: (800) 244-7668
Package insert: Influenza (inactivated, injectable)
Manufacturer/Distributor
Fluzone
Additional FDA information
Contact/order: (800) 822-2463
Package insert: Influenza (live, intranasal)
Manufacturer/Distributor
FluMist
Additional FDA information
Contact/order: (877) 358-6478
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FDA Licensure - Japanese encephalitis back to top
Package insert: Influenza (inactivated, injectable)
Manufacturer/Distributor
JE-Vax
Contact/order: (800) 822-2463
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FDA Licensure - Measles, mumps and rubella (MMR) back to top
Package insert: MMR
Manufacturer/Distributor
MMR II
Contact: (800) 672-6372
To order: (800) 637-2579
Package insert: MMR+Varicella (MMRV)
Manufacturer/Distributor
ProQuad - Refrigerator-stable
ProQuad - Frozen
Contact: (800) 672-6372
Additional FDA information
To order: (800) 637-2579
Package insert: Measles
Manufacturer/Distributor
Attenuvax
Contact: (800) 672-6372
To order: (800) 637-2579
Package insert: Rubella
Manufacturer/Distributor
Meruvax II
Contact: (800) 672-6372
To order: (800) 637-2579
Package insert: Mumps
Manufacturer/Distributor
Mumpsvax
Contact: (800) 672-6372
To order: (800) 637-2579
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FDA Licensure - Meningococcal back to top
Package insert: MPSV4
Manufacturer/Distributor
Menomune A/C/Y/W-135
Contact/order: (800) 822-2463
Package insert: MCV4
Manufacturer/Distributor
Menactra
Additional FDA information
Contact/order: (800) 822-2463
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FDA Licensure - Pneumococcal back to top
Package insert: PCV7
Manufacturer/Distributor
Prevnar
Additional FDA information
Contact/order: (800) 999-9384
Package insert: PPV23
Manufacturer/Distributor
Pneumovax 23
Contact: (800) 672-6372
To order: (800) 637-2579
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FDA Licensure - Polio back to top
Package insert: IPV
Manufacturer/Distributor
IPOL
Additional FDA information
Contact/order: (800) 822-2463
Package insert: IPV+DTaP+HepB
Manufacturer/Distributor
Pediarix
Additional FDA information
Contact/order: (800) 822-2463
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FDA Licensure - Rabies back to top
Package insert:
Manufacturer/Distributor
Imovax
Contact/order: (800) 822-2463
Package insert:
Manufacturer/Distributor
RabAvert
Contact/order: (800) 244-7668
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FDA Licensure - Rotavirus back to top
Package insert:
Manufacturer/Distributor
Rotarix
Additional FDA information
Contact/order: (866) 475-8222
Package insert:
Manufacturer/Distributor
RotaTeq
Additional FDA information
Contact: (800) 672-6372
To order: (800) 637-2579
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FDA Licensure - Smallpox back to top
Package insert:
Manufacturer/Distributor
ACAM2000
Acambis Inc
Additional FDA information
Available only through CDC or DoD
Package insert:
Manufacturer/Distributor
Dryvax
Additional FDA information
Contact: (800) 999-9384
To order: (800) 582-8221
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FDA Licensing - Td back to top
Package insert:
Manufacturer/Distributor
DECAVAC
Additional FDA information
Contact/order: (800) 822-2463
Package insert:
Manufacturer/Distributor
TENIVAC
Additional FDA information
Contact/order: (800) 822-2463
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FDA Licensing - Tdap back to top
Package insert:
Manufacturer/Distributor
Adacel
Additional FDA information
Contact/order: (800) 822-2463
Package insert:
Manufacturer/Distributor
Boostrix
Additional FDA information
Contact/order: (866) 475-8222
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FDA Licensing - Typhoid back to top
Package insert: Typhoid, inactivated, injectable
Manufacturer/Distributor
TYPHIM Vi
Contact: (800) 822-2463
Package insert: Typhoid, live
Manufacturer/Distributor
Vivotif
Contact/order: (800) 533-5899
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FDA Licensure - Varicella (chickenpox) back to top
Package insert:
Manufacturer/Distributor
Varivax - Refrigerator-stable formulation
Varivax - Frozen
Contact: (800) 672-6372
Additional FDA information
To order: (800) 637-2579
Package insert: Varicella+MMR (MMRV)
Manufacturer/Distributor
ProQuad - Refrigerator-stable
ProQuad - Frozen
Contact: (800) 672-6372
Additional FDA information
To order: (800) 637-2579
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FDA Licensure - Yellow fever back to top
Package insert:
Manufacturer/Distributor
YF-Vax
Contact: (800) 822-2463
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FDA Licensure - Zoster (shingles) back to top
Package insert:
Manufacturer/Distributor
Zostavax
Contact: (800) 672-6372
To order: (800) 637-2579
This page was reviewed on February 12, 2008.
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