Glossary

Filter by name: ALL A B C D F G L M N O P R S T
A
  • 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, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.  Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.

  • Abbreviated New Drug Application (ANDA) Number

    This six-digit number is assigned by FDA staff to each application for approval to market a generic drug in the United States.

  • Active Ingredient

    An active ingredient is any component that provides pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or animals.

  • Application

    See New Drug Application (NDA),  Abbreviated New Drug Application ANDA), or Biologic License Application (BLA)

  • Application Number

    See FDA Application Number

  • Approval History

    The approval history is a chronological list of all FDA actions involving one drug product having a particular FDA Application number (NDA).  There are over 50 kinds of approval actions including changes in the labeling, a new route of administration, and a new patient population for a drug product.

  • Approval Letter

    An official communication from FDA to a new drug application (NDA) sponsor that allows the commercial marketing of the product.