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U.S. Food and Drug Administration

Trade NameProduct Name / DiseasesManufacturerLast Label UpdateInitial U.S. ApprovalPackage InsertLast Approval Letter Update
ACAM2000Smallpox (Vaccinia) Vaccine, LiveEmergent Product Development GaithersburgMarch 20182007pdf iconMay 2 2017
ActHIBHaemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)Sanofi Pasteur17 May 2019 1993pdf iconMay 24 2019
AdacelTetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, AdsorbedSanofi PasteurDecember 20202005pdf iconDecember 28 2020
AfluriaInfluenza Virus Vaccine
(Trivalent, Types A and B)
SeqirusDecember 20192007pdf iconAugust 27 2020
AgrifluInfluenza Virus Vaccine
(Trivalent, Types A and B)
Seqirus10 January 20202009pdf iconJanuary 28 2020
BCG VaccineBCG VaccineOrganon Teknika CorpNot indicated in package insertNot indicated in package insertpdf icon13 January 2011
BexseroMeningococcal Group B VaccineNovartis Vaccines and DiagnosticsNot indicated in package insert2015pdf iconOctober 24 2019 2020
BiothraxAnthrax Vaccine AdsorbedEmergent BioDefense Operations Lansing November 20151970pdf icon23 November 2015
BoostrixTetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, AdsorbedGlaxoSmithKline BiologicalsSeptember 20202005pdf iconSeptember 10 2020
CervarixHuman Papillomavirus Bivalent (Types 16, 18) Vaccine, RecombinantGlaxoSmithKline BiologicalsNot indicated in package insert2009pdf icon13 February 2015
DaptacelDiphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine AdsorbedSanofi PasteurNot indicated in package insert2002pdf iconSeptember 16 2016
Engerix-BHepatitis B Vaccine (Recombinant)GlaxoSmithKline BiologicalsNot indicated in package insert1989pdf iconDecember 19 2018
FLUADInfluenza Vaccine, AdjuvantedSeqirusNovember 2015October 2020pdf iconOctober 28 2020
FluarixInfluenza Virus Vaccine
(Trivalent, Types A and B)
GlaxoSmithKline BiologicalsNot indicated in package insert 2005pdf icon30 June 2015
Fluarix QuadrivalentInfluenza Virus Vaccine
(Quadrivalent, Types A and Types B)
GlaxoSmithKline Biologicals20202012pdf iconJuly 2 2020
FlublokInfluenza Vaccine (Trivalent)Protein Sciences CorporationMarch 20172013pdf iconJuly 7 2017
Flublok QuadrivalentInfluenza Vaccine (Trivalent)Protein Sciences CorporationJune 20202013pdf iconJuly 2 2020
FluLavalInfluenza Virus Vaccine
(Trivalent, Types A and B)
ID Biomedical Corp of QuebecNovember 20162006pdf iconFebruary 6 2020
FluLaval
Quadrivalent
Influenza Virus Vaccine
(Quadrivalent, Types A and Types B)
ID Biomedical Corporation of Quebec20202013pdf iconJuly 2 2020
FluMistInfluenza Vaccine, Live, Intranasal
(Trivalent, Types A and B)
MedImmuneJuly 20152003pdf iconJuly 2 2020 2020
FluMist QuadrivalentInfluenza Vaccine,Live, Intranasal
(Quadrivalent, Types A and Types B)
MedImmuneAugust 20202003pdf iconJuly 2 2020 2020
FluvirinInfluenza Virus Vaccine
(Trivalent, Types A and B)
Seqirus VaccinesMarch 20171988pdf iconJuly 7 2017
FluzoneInfluenza Virus Vaccine
(Trivalent, Types A and B)
Sanofi Pasteur20151980pdf iconJuly 28 2018
Fluzone High-DoseInfluenza Virus Vaccine
(Trivalent, Types A and B)
Sanofi Pasteur29 March 20192009pdf iconJuly 2 2019
Fluzone IntradermalInfluenza Virus Vaccine
(Trivalent, Types A and B)
Sanofi Pasteur2 March 20172014pdf iconJuly 2 2019
GardasilHuman Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, RecombinantMerck & Co.April 20152006pdf icon24 April 2015
Gardasil 9Human Papillomavirus 9-valent Vaccine, RecombinantMerck & Co.August 20202014pdf iconAugust 20 2020
HavrixHepatitis A Vaccine, InactivatedGlaxoSmithKline BiologicalsNot indicated in package insert1995pdf iconDecember 19 2018
HiberixHaemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)GlaxoSmithKline BiologicalsApril 20182009pdf iconDecember 19 2018
ImovaxRabies VaccineSanofi PasteurOctober 2019Not indicated in package insertpdf iconOctober 25 2019
InfanrixDiphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine AdsorbedGlaxoSmithKline BiologicalsNot indicated in package insert1997pdf iconNovember 6 2019
IPOLPoliovirus Vaccine Inactivated (Monkey Kidney Cell)Sanofi PasteurNot indicated in package insertNot indicated in package insertpdf icon6 August 2015
IxiaroJapanese Encephalitis Virus Vaccine, Inactivated, AdsorbedIntercell BiomedicalSeptember 20182009pdf iconOctober 4 2018
JE-VaxJapanese Encephalitis Virus Vaccine InactivatedResearch Foundation for Microbial Diseases of Osaka UniversityDecember 2005Not indicated in package insertpdf iconNot indicated
KinrixDiphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus VaccineGlaxoSmithKline BiologicalsNot indicated in package insert2008pdf iconNovember 6 2019
M-M-R IIMeasles, Mumps, and Rubella Virus Vaccine, LiveMerck & Co.October 2015Not indicated in package insertpdf iconDecember 11 2020
MenactraMeningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate VaccineSanofi Pasteur26 April 20182005pdf iconApril 27 2018
MenHibrixMeningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate VaccineGlaxoSmithKline BiologicalsNot indicated in package insert2012pdf icon27 November 2013
Menomune-A/C/Y/W-135Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 CombinedSanofi Pasteur14 March 20161981pdf icon3 October 2013
MenveoMeningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate VaccineGlaxoSmithKline BiologicalsJuly 20202010pdf iconApril 27 2018
NoneAdenovirus Type 4 and Type 7 Vaccine, Live, OralBarr LabsApril 20142011pdf iconOctober 15 2019
NoneDiphtheria and Tetanus Toxoids AdsorbedSanofi PasteurJune 20181997pdf iconJune 6 2018
NoneInfluenza A (H1N1) 2009 Monovalent VaccineCSLNovember 20092007pdf icon10 November 2009
NoneInfluenza A (H1N1) 2009 Monovalent VaccineMedImmuneNot indicated in package insert2003pdf icon3 February 2010
NoneInfluenza A (H1N1) 2009 Monovalent VaccineID Biomedical Corporation of QuebecJanuary 20102006pdf icon10 November 2009
NoneInfluenza A (H1N1) 2009 Monovalent VaccineNovartis Vaccines and DiagnosticsSeptember 2009Not indicated in package insertpdf icon15 September 2009
NoneInfluenza A (H1N1) 2009 Monovalent VaccineSanofi Pasteur10 September 20091980pdf iconSeptember 15 2009
NoneInfluenza Virus Vaccine, H5N1 (for National Stockpile)Sanofi PasteurApril 20072007pdf icon17 April 2007
NoneInfluenza A (H5N1) Virus Monovalent Vaccine, AdjuvantedID Biomedical Corporation of QuebecNot indicated in package insert2013pdf icon22 November 2013
NoneDiphtheria & Tetanus Toxoids AdsorbedSanofi PasteurDecember 2005Not indicated in package insertpdf icon29 December 2003
NoneTetanus Toxoid AdsorbedSanofi PasteurJune 20181997pdf iconDecember 20 2018
PediarixDiphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed, Hepatitis B (recombinant) and Inactivated Poliovirus Vaccine CombinedGlaxoSmithKline BiologicalsNot indicated in package insert2002pdf iconNovember 6 2019
PedvaxHIBHaemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)Merck & Co.1998Not indicated in package insertpdf icon27 April 2011
PentacelDiphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) VaccineSanofi PasteurNot indicated in package insert2008pdf icon18 October 2013
Pneumovax 23Pneumococcal Vaccine, PolyvalentMerck Sharp & Dohme CorpSeptember 20201983pdf iconSeptember 25 2020
Prevnar 13Pneumococcal 13-valent Conjugate Vaccine
(Diphtheria CRM197 Protein)
Wyeth Pharmaceuticals20152010pdf icon22 May 2015
ProQuad (Frozen Formulation - Recombinant Human Albumin (RHA))Measles, Mumps, Rubella and Varicella Virus Vaccine LiveMerck Sharpe & Dohme CorpNot indicated in package insert2005pdf iconSeptember 15 2020
ProQuad (Frozen Formulation - Human SerumAlbumin (HSA))Measles, Mumps, Rubella and Varicella Virus Vaccine LiveMerck Sharpe & Dohme CorpNot indicated in package insert2005pdf iconSeptember 15 2020
ProQuad (Refrigerator-Stable Formulation)Measles, Mumps, Rubella and Varicella Virus Vaccine LiveMerck Sharpe & Dohme CorpOctober 20152005pdf iconSeptember 15 2020
QuadracelDiphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus VaccineSanofi PasteurDecember 20192015pdf iconDecember 19 2019
RabAvertRabies VaccineNovartis Vaccines and DiagnosticsNot indicated in package insertNot indicated in package insertpdf iconDecember 19 2019
Recombivax HBHepatitis B Vaccine (Recombinant)Merck & Co.December 20181986pdf iconDecember 21 2018
ROTARIXRotavirus Vaccine, Live, OralGlaxoSmithKline BiologicalsNot indicated in package insert2008pdf iconNovember 21 2019
RotaTeqRotavirus Vaccine, Live, Oral, PentavalentMerck & Co.June 20132006pdf icon13 June 2013
TenivacTetanus & Diphtheria Toxoids Adsorbed for Adult UseSanofi PasteurApril 20132003pdf icon25 October 2013
TICE BCGBCG LiveOrganon Teknika CorpFebruary 2009Not indicated in package insertpdf icon16 December 2010
TrumenbaMeningococcal Group B VaccineWyeth PharmaceuticalsOctober 20142014pdf icon9 December 2014
TwinrixHepatitis A Inactivated and Hepatitis B (Recombinant) VaccineGlaxoSmithKline BiologicalsMarch 20152001pdf icon7 August 2015
Typhim ViTyphoid Vi Polysaccharide VaccineSanofi PasteurMarch 2014Not indicated in package insertpdf icon27 March 2014
VAQTAHepatitis A Vaccine, InactivatedMerck & Co.Not indicated in package insert1996pdf icon10 July 2012
Varivax (Frozen)Varicella Virus Vaccine LiveMerck & Co.20131995pdf icon28 March 2014
Varivax (Refrigerator)Varicella Virus Vaccine LiveMerck & Co.20131995pdf icon28 March 2014
VivotifTyphoid Vaccine Live Oral Ty21aBerna BiotechSeptember 2013Not indicated in package insertpdf iconNot indicated
YF-VaxYellow Fever VaccineSanofi Pasteur2 May 2013Not indicated in package insertpdf icon19 December 2013
Zostavax
(Refrigerator Stable)
Zoster Vaccine, Live, (Oka/Merck)Merck & Co.February 20142006pdf icon17 February 2016
Zostavax (Frozen)Zoster Vaccine, Live, (Oka/Merck)Merck & Co.February 20162006pdf icon17 February 2016

 

No Longer Available Vaccines

Trade NameProduct Name / DiseasesManufacturerLast Label UpdateInitial U.S. ApprovalPackage InsertLast Approval Letter Update
ComvaxHaemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) & Hepatitis B Vaccine (Recombinant)Merck & Co.2001Not indicated in package insertpdf icon20 April 2011
NoneTetanus ToxoidSanofi PasteurDecember 2005Not indicated in package insertpdf iconNot indicated

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