Abbreviated New Drug Application (ANDA)An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs…
Active IngredientAn active ingredient is any component that provides pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or…
AddictionUncontrollable craving, seeking, and use of a substance such as a drug or alcohol.
agonistA drug that triggers an action from a cell or another drug.
antagonistIn medicine, a substance that stops the action or effect of another substance. For example, a drug that blocks the stimulating effect of estrogen on a…
ApplicationUnder the Equal Credit Opportunity Act (ECOA), an oral or written request for an extension of credit that is made in accordance with the procedures…
Approval HistoryThe approval history is a chronological list of all FDA actions involving one drug product having a particular FDA Application number (NDA).
Approval LetterAn official communication from FDA to a new drug application (NDA) sponsor that allows the commercial marketing of the product.