FDA Approvals | Small molecule

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

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
histamineJubilant Innovation Ltd.1924 - 19921924 - 199240Small molecule
butabarbitalMylan1939 - 19941939131Small molecule
desoxycorticosterone pivalateOrganon1939 - 19421939 - 194230Small molecule
guanidineMerck1939193910Small molecule
heparinOrganon1939 - 20231939 - 20233554Small molecule
sulfapyridineEli Lilly1939193910Small molecule
verardVerard Company1939193910Small molecule
aminophyllineG D Searle1940 - 19911940 - 1984364Small molecule
inulinIsoTex1940194010Small molecule
sulfurAH Robins1940194010Small molecule
ergocalciferolValidus Pharmaceuticals1941 - 20181941 - 20041013Small molecule
estroneParke-Davis1941 - 1979194114Small molecule
kappadioneRoche1941194120Small molecule
sulfadiazineAmerican Cyanamid1941 - 19941941 - 1949612Small molecule
sulfasalazineAmerican Cyanamid1941 - 20251941 - 2000513Small molecule
meperidineHospira1942 - 20091942 - 1961346Small molecule
ethinyl estradiolSchering1943 - 20261943 - 202481292Small molecule
homatropineGenus Oncology, LLC1943 - 20191943117Small molecule
hydrocodoneGenus Oncology, LLC1943 - 20211943 - 201813193Small molecule
methamphetamineKEY THERAP1943 - 2015194316Small molecule
1,949 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