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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, LiveSanofi Pasteur BiologicsDecember 20152007pdf icon5 February 2015
ActHIBHaemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)Sanofi Pasteur15 December 2015 1993pdf icon16 December 2015
AdacelTetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, AdsorbedSanofi PasteurNot indicated in package insert2005pdf icon11 February 2015
AfluriaInfluenza Virus Vaccine
(Trivalent, Types A and B)
CSL LimitedMarch 20162007pdf icon24 March 2016
AgrifluInfluenza Virus Vaccine
(Trivalent, Types A and B)
Novartis Vaccines and Diagnostics15 October 20132009pdf icon21 October 2013
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 icon23 January 2015
BiothraxAnthrax Vaccine AdsorbedEmergent BioDefense Operations Lansing November 20151970pdf icon23 November 2015
BoostrixTetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, AdsorbedGlaxoSmithKline BiologicalsNot indicated in package insert2005pdf icon27 November 2013
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 icon25 October 2013
DecavacTetanus & Diphtheria Toxoids Adsorbed for Adult UseSanofi PasteurMarch 20111955pdf icon7 March 2011
Engerix-BHepatitis B Vaccine (Recombinant)GlaxoSmithKline BiologicalsNot indicated in package insert1989pdf icon15 September 2015
FLUADInfluenza Vaccine, AdjuvantedNovartis Vaccines and DiagnosticsNovember 2015Not indicated in package insertpdf icon24 November 2015
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 Biologicals20142012pdf icon27 June 2014
FlublokInfluenza Vaccine (Trivalent)Protein Sciences CorporationApril 20152013pdf icon1 July 2015
FlucelvaxInfluenza Virus Vaccine
(Trivalent, Types A and B)
Novartis Vaccines and DiagnosticsMay 20152012pdf icon2 July 2015
FluLavalInfluenza Virus Vaccine
(Trivalent, Types A and B)
ID Biomedical Corp of QuebecNot indicated in package insert2006pdf icon30 June 2015
FluLaval
Quadrivalent
Influenza Virus Vaccine
(Quadrivalent, Types A and Types B)
ID Biomedical CorporationNot indicated in package insert2013pdf icon27 June 2014
FluMistInfluenza Vaccine, Live, Intranasal
(Trivalent, Types A and B)
MedImmuneJuly 20152003pdf icon14 August 2015
FluMist QuadrivalentInfluenza Vaccine,Live, Intranasal
(Quadrivalent, Types A and Types B)
MedImmuneNot indicated in package insert2003pdf icon13 February 2015
FluvirinInfluenza Virus Vaccine
(Trivalent, Types A and B)
Novartis Vaccines and DiagnosticsFeb 20151988pdf icon2 July 2015
FluzoneInfluenza Virus Vaccine
(Trivalent, Types A and B)
Sanofi Pasteur1 May 20151980pdf icon26 June 2015
Fluzone High-DoseInfluenza Virus Vaccine
(Trivalent, Types A and B)
Sanofi Pasteur26 February 20152009pdf icon26 June 2015
Fluzone IntradermalInfluenza Virus Vaccine
(Trivalent, Types A and B)
Sanofi Pasteur3 June 20142011pdf icon26 June 2015
Fluzone QuadrivalentInfluenza Virus Vaccine
(Quadrivalent, Types A and Types B)
Sanofi Pasteur17 June 20152013pdf icon29 September 2015
GardasilHuman Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, RecombinantMerck & Co.April 20152006pdf icon24 April 2015
Gardasil 9Human Papillomavirus 9-valent Vaccine, RecombinantMerck & Co.December 20152014pdf icon14 December 2015
HavrixHepatitis A Vaccine, InactivatedGlaxoSmithKline BiologicalsNot indicated in package insert1995pdf icon25 November 2013
HiberixHaemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)GlaxoSmithKline BiologicalsNot indicated in package insert2009pdf icon14 January 2016
ImovaxRabies VaccineSanofi Pasteur25 April 2013Not indicated in package insertpdf icon3 July 2013
InfanrixDiphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine AdsorbedGlaxoSmithKline BiologicalsNot indicated in package insert1997pdf icon27 November 2013
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 BiomedicalAugust 20152009pdf icon24 February 2016
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 icon23 July 2014
M-M-R IIMeasles, Mumps, and Rubella Virus Vaccine, LiveMerck & Co.October 2015Not indicated in package insertpdf icon22 October 2015
MenactraMeningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate VaccineSanofi Pasteur26 August 20142005pdf icon4 September 2014
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 Pasteur15 April 20131981pdf icon3 October 2013
MenveoMeningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate VaccineNovartis Vaccines and DiagnosticsAugust 20132010pdf icon1st August 2013
NoneAdenovirus Type 4 and Type 7 Vaccine, Live, OralBarr LabsApril 20142011pdf icon20 October 2014
NoneTetanus & Diphtheria Toxoids, Adsorbed_MassBiologicsMassBiologicsApril 2009Not indicated in package insertpdf icon19 March 2014
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 icon15 September 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 insertNot indicated in package insertpdf icon22 November 2013
NoneDiphtheria & Tetanus Toxoids AdsorbedSanofi PasteurDecember 2005Not indicated in package insertpdf icon29 December 2003
NoneTetanus Toxoid AdsorbedSanofi PasteurNot indicated in package insert1997pdf icon14 June 2013
PediarixDiphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed, Hepatitis B (recombinant) and Inactivated Poliovirus Vaccine CombinedGlaxoSmithKline BiologicalsNot indicated in package insert2002pdf icon27 November 2013
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 & Co.Not indicated in package insert1983pdf icon30 December 2014
PrevnarPneumococcal 7-valent Conjugate Vaccine
(Diphtheria CRM197 Protein)
Wyeth PharmaceuticalsNot indicated in package insertNot indicated in package insertpdf icon1 October 2002
Prevnar 13Pneumococcal 13-valent Conjugate Vaccine
(Diphtheria CRM197 Protein)
Wyeth Pharmaceuticals20152010pdf icon22 May 2015
ProQuad (Frozen Formulation) Measles, Mumps, Rubella and Varicella Virus Vaccine LiveMerck & Co.October 20152005pdf icon22 October 2015
ProQuad (Refrigerator-Stable Formulation)Measles, Mumps, Rubella and Varicella Virus Vaccine LiveMerck & Co.October 20152005pdf icon22 October 2015
QuadracelDiphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus VaccineSanofi PasteurNot indicated in package insertNot indicated in package insertpdf icon24 March 2015
RabAvertRabies VaccineNovartis Vaccines and DiagnosticsNovember 2013Not indicated in package insertpdf icon18 November 2015
Recombivax HBHepatitis B Vaccine (Recombinant)Merck & Co.Not indicated in package insert1983pdf icon20 May 2014
ROTARIXRotavirus Vaccine, Live, OralGlaxoSmithKline BiologicalsSeptember 20142008pdf icon27 February 2015
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