(from www.gmp1st.com/drglos). Abbreviated New Drug Application

Abbreviated New Drug Applications

an application by a drug manufacturer to receive authority to market a generic version of an approved product, by demonstrating that it has the same properties as the original approved product

A simplified submission permitted for a duplicate of an already approved drug. ANDAs are for products with the same or very closely related active ingredients, dosage form, strength, administration route, use, and labeling as a product that has already been shown to be safe and effective. An ANDA includes all the information on chemistry and manufacturing controls found in a new drug application (NDA), but does not have to include data from studies in animals and humans. It must, however, contain evidence that the duplicate drug is bioequivalent (see "Bioequivalence") to the previously approved drug.

Abbreviated New Drug Appplication

Abbreviated New Drug Application (filed with the FDA).

Abbreviated New Drug Application. Absorption, Distribution, Metabolism and Excretion/Toxicology (ADME/T) Action Letter

Abbreviated New Drug Application (for a generic drug; FDA)

An Abbreviated New Drug Application (ANDA) is an application for a US generic drug approval for an existing licensed medication or approved drug.