FDA Approvals | Botanical

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
protein hydrolysatesB. Braun1947194720Botanical
soybean oilFresenius1975 - 20161975 - 2016170Botanical
safflower oilAbbott1979 - 19841979 - 198440Botanical
celluloseMission Pharmacal1982 - 19981982 - 199820Botanical
podofiloxTeva1990 - 20231990 - 199723Botanical
omega-3 fatty acidsWoodward2004 - 20232004 - 2014315Botanical
teaAni Pharmaceuticals2006200610Botanical
oliveBaxalta2013 - 20162013 - 201620Botanical
anacaulaseMediWound Ltd2022202210Botanical
birch triterpenesChiesi2023202310Botanical
veratrum viride rootMedpointe10Botanical
11 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