Food and Drug Administration

Adenovirus		Hib		Mumps		Td
Anthrax		Hepatitis A		Pneumococcal - PCV		Tdap
BCG		Hepatitis B		Pneumococcal - PPSV		Tick-borne Encephalitis
Cholera		HPV		Polio - IPV		Typhoid
COVID-19		Influenza		Rabies		Varicella (chickenpox)
Dengue		Japanese encephalitis		Respiratory Syncytial Virus (RSV)		Yellow fever
DT		Measles		Rotavirus		Zoster (shingles)
DTaP		Meningococcal ACWY		Rubella
Ebola virus		Meningococcal B		Smallpox and Monkeypox

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 Back to top
Vaxchora Package Insert Emergent BioSolutions Vaxchora Product Approval
Product Approval - FDA Approval and Emergency Use Authorization (EUA) – COVID-19 Back to top
Comirnaty Package Insert Pfizer-BioNTech Comirnaty Product Approval		Spikevax Package Insert Moderna Spikevax Product Approval
EUA Full Prescribing Information Pfizer-BioNTech Letter of Authorization  Fact Sheet for Healthcare Providers  Fact Sheets for Patients		EUA Full Prescribing Information Moderna Letter of Authorization  Fact Sheet for Healthcare Providers  Fact Sheets for Patients
EUA Full Prescribing Information Janssen (Johnson and Johnson) Letter of Authorization  Fact Sheet for Healthcare Providers  Fact Sheet for Patients		EUA Full Prescribing Information Novavax, Inc Letter of Authorization  Fact Sheet for Healthcare Providers  Fact Sheets for Patients
Product Approval - Dengue Back to top
Dengvaxia Package Insert Sanofi U.S. Dengvaxia Product Approval
Product Approval - DT
DT (generic) Package Insert Sanofi U.S. DT (generic) Product Approval
Product Approval - DTaP
Daptacel Package Insert Sanofi U.S. Daptacel Product Approval		Pentacel Package Insert Sanofi U.S. Pentacel Product Approval
Infanrix Package Insert GSK Infanrix Product Approval		Quadracel Package Insert Sanofi U.S. Quadracel Product Approval
Kinrix Package Insert GSK Kinrix Product Approval		Vaxelis Package Insert Sanofi U.S. Vaxelis Product Approval
Pediarix Package Insert GSK Pediarix Product Approval
Product Approval - Ebola virus disease (EVD) Ervebo Package Insert Merck & Co, Inc. Ervebo Product Approval
Product Approval - Haemophilus influenzae type b Back to top
ActHIB Package Insert Sanofi U.S. ActHIB Product Approval		Pentacel Package Insert Sanofi U.S. Pentacel Product Approval
Hiberix Package Insert GSK Hiberix Product Approval		Vaxelis Package Insert Sanofi U.S. Vaxelis Product Approval
PedvaxHIB Package Insert Merck & Co., Inc. PedvaxHIB Product Approval
Product Approval - Hepatitis A
Havrix Package Insert GSK Havrix Product Approval		Vaqta Package Insert Merck & Co., Inc. Vaqta Product Approval
Twinrix Package Insert GSK Twinrix Product Approval
Product Approval - Hepatitis B Back to top
Engerix-B Package Insert GSK Engerix-B Product Approval		Recombivax HB Package Insert Merck & Co., Inc. Recombivax HB Product Approval
Heplisav-B Package Insert Dynavax Technologies Heplisav-B Product Approval		Twinrix Package Insert GSK Twinrix Product Approval
Pediarix Package Insert GSK Pediarix Product Approval		Vaxelis Package Insert Sanofi U.S. Vaxelis Product Approval
PreHevbrio Package Insert VBI Vaccines Inc. PreHevbrio Product Approval
Product Approval - Human papillomavirus (HPV)
Gardasil 9 Package Insert Merck & Co., Inc. Gardasil 9 Product Approval
Product Approval - Influenza Back to top
Afluria Quadrivalent Package Insert Seqirus Afluria Quadrivalent Product Approval (injectable)		FluLaval Quadrivalent Package Insert ID Biomedical Corporation FluLaval Quadrivalent Product Approval (injectable)
Fluad Quadrivalent Package Insert Seqirus Fluad Quadrivalent Product Approval (injectable)		FluMist Quadrivalent Package Insert MedImmune, Inc. FluMist Quadrivalent Product Approval (intranasal)
Fluarix Quadrivalent Package Insert GSK Fluarix Quadrivalent Product Approval (injectable)		Fluzone High Dose Quadrivalent Package Insert Sanofi U.S. Fluzone High Dose Quadrivalent Product Approval (injectable)
Flublok Quadrivalent Package Insert Protein Sciences Corporation Flublok Quadrivalent Product Approval (injectable)		Fluzone Quadrivalent Package Insert Sanofi U.S. 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
Priorix Package Insert GSK Priorix Product Approval
Product Approval - Meningococcal ACWY Back to top
Menactra Package Insert Sanofi U.S. Menactra Product Approval		Menveo Package Insert GSK Menveo Product Approval
MenQuadfi Package Insert Sanofi U.S. MenQuadfi Product Approval
Product Approval - Meningococcal B Back to top
Bexsero Package Insert GSK Bexsero Product Approval		Trumenba Package Insert Pfizer Trumenba Product Approval
Product Approval - Mumps Back to top
MMR II Package Insert Merck & Co. MMR II Product Approval		ProQuad Package Insert Merck & Co. ProQuad Product Approval
Priorix Package Insert GSK Priorix Product Approval
Product Approval - Pneumococcal (PCV)
Prevnar 13 Package Insert Pfizer Prevnar 13 Product Approval		Vaxneuvance (PCV15) Package Insert Merck & Co, Inc. Vaxneuvance (PCV15) Product Approval
Prevnar 20 Package Insert Pfizer Prevnar 20 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 U.S. IPOL Product Approval		Pentacel Package Insert Sanofi U.S. Pentacel Product Approval
Kinrix Package Insert GSK Kinrix Product Approval		Quadracel Package Insert Sanofi U.S. Quadracel Product Approval
Pediarix Package Insert GSK Pediarix Product Approval		Vaxelis Package Insert Sanofi U.S. Vaxelis Product Approval
Product Approval - Rabies Back to top
Imovax Package Insert Sanofi U.S. Imovax Product Approval		RabAvert Package Insert Bavarian Nordic RabAvert Product Approval
Product Approval - Respiratory Syncytial Virus (RSV) Back to top
Arexvy Package Insert GSK Arexvy Product Approval
Product Approval - Rotavirus
Rotarix Package Insert GSK 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
Priorix Package Insert GSK Priorix Product Approval
Product Approval - Smallpox and Monkeypox
ACAM2000 Package Insert Emergent Biosolutions ACAM2000 Product Approval - (smallpox only)		Jynneos Package Insert Bavarian Nordic A/S Jynneos Product Approval
		EUA Full Prescribing Information Jynneos Letter of Authorization  Fact Sheet for Healthcare Providers  Fact Sheet for Patients
Product Approval - Tetanus (Td) Back to top
Td (generic) Package Insert Mass. Biological Lab Td (generic) Product Approval		Tenivac Package Insert Sanofi U.S. Tenivac Product Approval
Product Approval - Tetanus (Tdap)
Adacel Package Insert Sanofi U.S. Adacel Product Approval		Boostrix Package Insert GSK Boostrix Product Approval
Product Approval – Tick-borne encephalitis
Ticovac Package Insert Pfizer Ticovac Product Approval
Product Approval - Typhoid
Typhim Vi Package Insert Sanofi U.S. Typhim Vi Product Approval		Vivotif Package Insert Emergent BioSoulutions 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 Back to top
YF-Vax Package Insert Sanofi U.S. YF-Vax Product Approval
Product Approval - Zoster (shingles)
Shingrix Package Insert GSK Shingrix Product Approval
This page was updated on to May 15, 2023. This page was reviewed on May 3, 2023.