![]() ![]() See New Drug Application (NDA), Abbreviated New Drug Application ANDA), or Biologic License Application (BLA)Īn official communication from FDA to a new drug application (NDA) sponsor that allows the commercial marketing of the product.īiological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. 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. The approval history is a chronological list of all FDA actions involving one drug product having a particular FDA Application number (NDA). This six-digit number is assigned by FDA staff to each application for approval to market a generic drug in the United States.Īn 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. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.Ībbreviated New Drug Application (ANDA) Number ![]() Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). 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. ![]() A B C D E F G H I J K L M N O P Q R S T U V W X Y ZĪn 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. ![]()
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