Package Inserts & EUAs
FDA’s Center for Biologics Evaluation and Research regulates biological products, including vaccines, for human use. As part of their responsibility of ensuring that these products are safe and effective, they also approve product labeling, or package inserts.
Here we provide package inserts, product approvals, and other supporting documents listed alphabetically by vaccine, or use the filter to choose a specific vaccine.
Manufacturer’s contact information
Results (76)
Diphtheria & Tetanus: DT (generic) Package Insert
Sanofi U.S.
Diphtheria & Tetanus: Td (generic) Package Insert
MassBiologics
Diphtheria & Tetanus: Tenivac Package Insert
Sanofi U.S.
Ebola virus disease (EVD): Ervebo Package Insert
Merck & Co, Inc.
Hepatitis A & Hepatitis B: Twinrix Package Insert
GSK
Hepatitis A: Havrix Package Insert
GSK
Hepatitis A: Vaqta Package Insert
Merck & Co., Inc.
Hepatitis B: Engerix-B Package Insert
GSK
Hepatitis B: Heplisav-B Package Insert
Dynavax Technologies
Hepatitis B: PreHevbrio Package Insert
VBI Vaccines Inc.
Hepatitis B: Recombivax HB Package Insert
Merck & Co., Inc.
Hib: ActHIB Package Insert
Sanofi U.S.
Hib: Hiberix Package Insert
GSK
Hib: PedvaxHIB Package Insert
Merck & Co., Inc.
Human papillomavirus (HPV): Gardasil 9 Package Insert
Merck & Co., Inc.
Influenza: Afluria Quadrivalent Package Insert
Seqirus
Influenza: FluLaval Quadrivalent Package Insert
ID Biomedical Corporation
Influenza: FluMist Quadrivalent Package Insert
MedImmune, Inc.
Influenza: Fluad Quadrivalent Package Insert
Seqirus
Influenza: Fluarix Quadrivalent Package Insert
GSK