“ANDA” is the abbreviation for “Abbreviated New Drug Application”. It contains data which when submitted to FDA’s Center for Drug Evaluation & Research, Office of Generic Drug, provides for the review & ultimate approval of a generic drug product. Once approved an applicant may manufacture & market the generic drug product provided all issues related to patent protection, safe, effectiveness, low cost alternative to the public. Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical (animal) & clinical (human) data to establish safety & effectiveness. A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics & intended use.

This topic describes: ANDA Requirement, Signed FDA form 356h, Index, Information on the basis for which the ANDA is being submitted, Condition for use, active ingredient, Route of administration, dosage form & strength, Bioequivalence, Labeling, Chemistry, Manufacturing & Controls, Human Pharmacokinetics & Bioavailability, Samples, Analytical method for drug substance & drug product, Labeling and Case report forms & tabulations.

Abbreviated New Drug Application submission (ANDA)

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