Which type of application should a company submit to market a generic version of a medication?

The correct choice for a company seeking to market a generic version of a medication is the Abbreviated New Drug Application (ANDA). The ANDA process is specifically designed to streamline the approval of generic drugs, which are required to be therapeutically equivalent to their brand-name counterparts.

When a company submits an ANDA, it does not need to provide the same extensive clinical data required by a New Drug Application (NDA), as the safety and efficacy of the active ingredient have already been established by the original brand-name product. Instead, the focus for an ANDA is to demonstrate that the generic product is bioequivalent to the brand-name medication, meaning that it releases its active ingredient into the bloodstream at the same rate and to the same extent.

The need for a unique application type is essential because generics are a vital aspect of making medications more affordable and accessible. Thus, the ANDA process is crucial in maintaining both the integrity of the pharmaceutical market and the wellbeing of consumers who rely on generic medications. The other applications mentioned, such as the New Drug Application (NDA) and Investigational New Drug (IND), serve different purposes related to initial drug development and approval, while the National Drug Code (NDC) is more of a labeling