FDA approvals

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.

Top 5 innovator ingredients

Top 5 generic ingredients

Top 5 innovator sponsors

Top 5 generic sponsors

Earliest approvals by drug type

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
bee venomJubilant Innovation Ltd.1924 - 19911924 - 199120Animal product
bermuda grass pollen allergenJubilant Innovation Ltd.1924 - 19581924 - 195850Allergen
cat epidermis allergenJubilant Innovation Ltd.1924 - 19741924 - 197470Allergen
histamineJubilant Innovation Ltd.1924 - 19921924 - 199240Small molecule
house dust mite allergenJubilant Innovation Ltd.1924 - 20171924 - 2017110Allergen
kentucky bluegrass pollen allergenJubilant Innovation Ltd.1924 - 19501924 - 195050Allergen
lolium perenne pollenJubilant Innovation Ltd.1924 - 19501924 - 195050Allergen
meadow fescue grass pollen allergenJubilant Innovation Ltd.1924 - 19741924 - 197450Allergen
mixed vespid venom proteinJubilant Innovation Ltd.1924 - 19911924 - 199120Biological
orchard grass pollen allergenJubilant Innovation Ltd.1924 - 19741924 - 197450Allergen
redtop grass pollen allergenJubilant Innovation Ltd.1924 - 19741924 - 197450Allergen
short ragweed pollen allergenJubilant Innovation Ltd.1924 - 20141924 - 201470Allergen
sweet vernal grass pollen allergenJubilant Innovation Ltd.1924 - 19741924 - 197450Allergen
timothy grass pollen allergen extractJubilant Innovation Ltd.1924 - 20141924 - 201460Allergen
wasp venom proteinJubilant Innovation Ltd.1924 - 19911924 - 199120Biological
white faced hornet venom proteinJubilant Innovation Ltd.1924 - 19911924 - 199120Allergen
yellow hornet venom proteinJubilant Innovation Ltd.1924 - 19911924 - 199120Biological
yellow jacket venom proteinJubilant Innovation Ltd.1924 - 19911924 - 199120Biological
Antivenin (Latrodectus mactans) (Equine)Merck1936193610Animal product
butabarbitalMylan1939 - 19941939131Small molecule
2,504 ingredients
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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