FDA Approvals | Vaccine

Products regulated by the Food and Drug Administration comprise 25% of American consumer spending. The approaches used to approve these products can be as varied and complex as the products themselves. Such differences are dictated by Federal law and FDA identifies and enforces the relative risks and benefits that the products pose to consumers. These results convey summaries of products approved by FDA, including information about their past history and present status. The information not only applies to New Molecular Entities, but includes FDA approval information pertaining to new ingredients, dosages, therapeutic uses and generic equivalents.

Note: these approvals are sourced from Drugs@FDA and Purple Book, and do not currently reflect older FDA approvals and/or other evidence of US marketing.

Active Ingredients

Active IngredientInnovator SponsorApproval YearsInnovator YearsInnovatorGenericType
attenuated measles vaccine - Edmonston strainMerck1963 - 20051963 - 200520Vaccine
Mumps virus vaccine liveMerck1967196710Vaccine
rubella virus vaccine liveMerck1969 - 20051969 - 200520Vaccine
Tetanus and diphtheria toxoids adsorbedMassBiologics1970 - 20031970 - 200350Vaccine
measles, mumps, and rubella vaccineMerck1971 - 20221971 - 202220Vaccine
23-valent pneumococcal polysaccharide vaccineMerck1977197710Vaccine
hepatitis b vaccine (recombinant)Merck1986 - 20211986 - 202140Vaccine
bacille calmette-guerinOrganon1989 - 20001989 - 200040Vaccine
haemophilus influenzae type b conjugate vaccineMerck1989 - 20121989 - 201240Vaccine
typhoid vaccine, live oralEmergent BioSolutions1989198910Vaccine
plague vaccineGreer Laboratories1994199410Vaccine
hepatitis a vaccine, inactivatedGlaxoSmithKline1995 - 19961995 - 199620Vaccine
live attenuated varicella vaccineMerck1995 - 20061995 - 200630Vaccine
Haemophilus influenzae Type b Conjugate and Hepatitis B (Recombinant)Merck1996199610Vaccine
acellular pertussis vaccine (including diptheria and tetanus toxoids)GlaxoSmithKline1997 - 20021997 - 200230Vaccine
inactivated rabies vaccineBavarian Nordic1997 - 20001997 - 200020Vaccine
anthrax vaccine, adsorbedEmergent BioSolutions1998 - 20231998 - 202320Vaccine
inactivated influenza vaccineCSL Behring1998 - 20201998 - 2020120Vaccine
rabies vaccine adsorbedEmergent BioSolutions1998199810Vaccine
Tuberculin, Purified Protein DerivativePar Pharmaceuticals1998 - 20001998 - 200020Vaccine
69 ingredients
Page 1 / 4

Approval Applications

Appl NoTypeApprovalSponsorActive IngredientsMarketing StatusClassPriority?Links

Submission class glossary

TYPE 1
New Molecular Entity
TYPE 2
New Active Ingredient
TYPE 3
New Dosage Form
TYPE 4
New Combination
TYPE 5
New Formulation or New Manufacturer
TYPE 6
New Indication (pre-2009)
TYPE 7
Drug Already Marketed without Approved NDA
TYPE 8
Partial Rx to OTC Switch
TYPE 9
New Indication or Claim (existing NDA)
TYPE 10
New Indication or Claim (additional NDA)
MEDGAS
Medical Gas