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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 (75)
Adenovirus: Adenovirus Package Insert
Barr Labs Inc.
Anthrax: BioThrax Package Insert
Emergent BioSolutions
Anthrax: Cyfendus Package Insert
Emergent BioSolutions
BCG Package Insert
Organon Teknica (Merck)
COVID-19: Comirnaty Package Insert
COVID-19: Spikevax Package Insert
Cholera: Vaxchora Package Insert
Emergent BioSolutions
Combination Vaccine: Kinrix Package Insert
Combination Vaccine: Pediarix Package Insert
Combination Vaccine: Pentacel Package Insert
Sanofi U.S.
Combination Vaccine: ProQuad Package Insert
Merck & Co.
Combination Vaccine: Quadracel Package Insert
Sanofi U.S.
Combination Vaccine: Vaxelis Package Insert
MSP Vaccine Company
DTaP: Daptacel Package Insert
Sanofi U.S.
DTaP: Infanrix Package Insert
Dengue: Dengvaxia Package Insert
Sanofi U.S.
Diphtheria & Tetanus: DT (generic) Package Insert
Sanofi U.S.

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