Delaware Abbreviated New Drug Application (AND) is the legal document submitted to the U.S. Food and Drug Administration (FDA) by a pharmaceutical company to seek approval to market a generic drug in the United States. Andes may be submitted to the FDA for the approval of generic versions of both prescription and over-the-counter (OTC) drugs. The AND contains information about the generic drug's active ingredient, manufacturing process, bioequivalence, safety, effectiveness, and labeling. Delaware Abbreviated New Drug Applications (AND) come in two types: 505(j) AND 505(b)(2) AND. A 505(j) AND Ais an application for approval of a generic version of a previously approved drug. A 505(b)(2) AND Ais an application for approval of a new drug with certain components being reviewed through the 505(j) pathway. Both types of the Andes must demonstrate that the generic drug is bioequivalent in terms of safety, effectiveness, and performance to the brand-name drug.
Delaware Abbreviated New Drug Application (ANDA)
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