Results for tag: "Abbreviated New Drug Application"

An Abbreviated New Drug Application (ANDA) is a type of application used by generic drug manufacturers to gain approval from the U.S. Food and Drug Administration (FDA) to market a generic drug. The ANDA process is designed to provide a streamlined pathway for generic drug manufacturers to gain approval to market a generic version of a brand-name drug. The ANDA process requires generic drug manufacturers to demonstrate that their generic drug is bioequivalent to the brand-name drug, meaning that it has the same active ingredients, strength, dosage form, and route of administration as the brand-name drug. Generic drugs are typically much less expensive than brand-name drugs, making them an attractive option for consumers. Generic drugs are also beneficial for the healthcare system, as they can help reduce healthcare costs. Some companies in the ANDA market include Mylan, Teva Pharmaceuticals, Sandoz, and Sun Pharmaceuticals. Show Less Read more