Food and Drug Administration

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

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 PaxVax Vaxchora Product Approval
Product Approval - DT
DT (generic) Package Insert Sanofi Pasteur DT (generic) Product Approval
Product Approval - DTaP
Daptacel Package Insert Sanofi Pasteur Daptacel Product Approval		Pediarix Package Insert GlaxoSmithKline Pediarix Product Approval
Infanrix Package Insert GlaxoSmithKline Infanrix Product Approval		Pentacel Package Insert Sanofi Pasteur Pentacel Product Approval
Kinrix Package Insert GlaxoSmithKline Kinrix Product Approval		Quadracel Package Insert Sanofi Pasteur Quadracel Product Approval
Product Approval - Haemophilus influenzae type b Back to top
ActHIB Package Insert Sanofi Pasteur ActHIB Product Approval		PedvaxHIB Package Insert Merck & Co., Inc. PedvaxHIB Product Approval
Hiberix Package Insert GlaxoSmithKline Hiberix Product Approval		Pentacel Package Insert Sanofi Pasteur Pentacel Product Approval
Menhibrix Package Insert GlaxoSmithKline Menhibrix Product Approval
Product Approval - Hepatitis A
Havrix Package Insert GlaxoSmithKline Havrix Product Approval		Vaqta Package Insert Merck & Co., Inc. Vaqta Product Approval
Twinrix Package Insert GlaxoSmithKline Twinrix Product Approval
Product Approval - Hepatitis B Back to top
Engerix-B Package Insert GlaxoSmithKline Engerix-B Product Approval		Recombivax HB Package Insert Merck & Co., Inc. Recombivax HB Product Approval
Pediarix Package Insert GlaxoSmithKline Pediarix Product Approval		Twinrix Package Insert GlaxoSmithKline Twinrix Product Approval
Product Approval - Human papillomavirus (HPV)
Gardasil Package Insert Merck & Co., Inc. Gardasil Product Approval		Gardasil 9 Package Insert Merck & Co., Inc. Gardasil 9 Product Approval
Product Approval - Influenza Back to top
Afluria Package Insert Seqirus Afluria Product Approval (injectable)		FluLaval Quadrivalent Package Insert GlaxoSmilthKline FluLaval Quadrivalent Product Approval (injectable)
Afluria Quadrivalent Package Insert Seqirus Afluria Quadrivalent Product Approval (injectable)		FluMist Quadrivalent Package Insert MedImmune, Inc. FluMist Quadrivalent Product Approval (intranasal)
Fluad Package Insert Seqirus Fluad Product Approval (injectable)		Fluvirin Package Insert Seqirus (Novartis) Fluvirin Product Approval (injectable)
Fluarix Quadrivalent Package Insert GlaxoSmithKline Fluarix Quadrivalent Product Approval (injectable)		Fluzone High-Dose Package Insert Sanofi Pasteur Fluzone High-Dose Product Approval (injectable)
Flublok Package Insert Protein Sciences Corporation Flublok Product Approval (injectable)		Fluzone Intradermal Package Insert Sanofi Pasteur Fluzone Intradermal Product Approval (injectable)
Flublok Quadrivalent Package Insert Protein Sciences Corporation Flublok Quadrivalent Product Approval		Fluzone Quadrivalent Package Insert Sanofi Pasteur 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
Product Approval - Meningococcal ACWY Back to top
Menactra Package Insert Sanofi Pasteur Menactra Product Approval		Menomune A/C/Y/W-135 Package Insert Sanofi Pasteur Menomune A/C/Y/W-135 Product Approval
Menhibrix Package Insert GlaxoSmithKline Menhibrix Product Approval		Menveo Package Insert Glaxo Smith Kline Menveo Product Approval
Product Approval - Meningococcal B Back to top
Bexsero Package Insert GlaxoSmithKline 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
Product Approval - Pneumococcal (PCV)
Prevnar Package Insert Pfizer Prevnar 13 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 Pasteur IPOL Product Approval		Pentacel Package Insert Sanofi Pasteur Pentacel Product Approval
Kinrix Package Insert GlaxoSmithKline Kinrix Product Approval		Quadracel Package Insert Sanofi Pasteur Quadracel Product Approval
Pediarix Package Insert GlaxoSmithKline Pediarix Product Approval
Product Approval - Rabies Back to top
Imovax Package Insert Sanofi Pasteur Imovax Product Approval		RabAvert Package Insert Glaxo Smith Kline RabAvert Product Approval
Product Approval - Rotavirus
Rotarix Package Insert GlaxoSmithKline 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
Product Approval - Smallpox
ACAM2000 Package Insert Sanofi Pasteur ACAM2000 Product Approval
Product Approval - Tetanus (Td) Back to top
Td (generic) Package Insert Mass. Biological Lab Td (generic) Product Approval		Tenivac Package Insert Sanofi Pasteur Tenivac Product Approval
Product Approval - Tetanus (Tdap)
Adacel Package Insert Sanofi Pasteur Adacel Product Approval		Boostrix Package Insert GlaxoSmithKline Boostrix Product Approval
Product Approval - Typhoid
Typhim Vi Package Insert Sanofi Pasteur Typhim Vi Product Approval		Vivotif Package Insert PaxVax 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 Pasteur YF-Vax Product Approval
Product Approval - Zoster (shingles)
Zostavax Package Insert Merck & Co., Inc. Zostavax Product Approval
This page was updated on April 6, 2017. This page was reviewed on April 6, 2017.