What submission is made after marketing to change production and packaging, or introduce a new dosage form or indication?

The correct response here is based on the understanding of regulatory submissions made to the FDA concerning changes or updates related to a drug’s production, packaging, or formulation. A Supplement New Drug Application (SNDA) is specifically designed for situations where a manufacturer seeks to introduce changes, such as modifications in production processes, packaging alterations, or the introduction of a new dosage form or indication for an existing drug that is already marketed.

This type of submission is crucial because it ensures that the FDA is informed about these changes and can assess them for safety and efficacy, in order to maintain the integrity of the drug's approval status. It reflects regulatory compliance, ensuring that all modifications comply with established standards, which is essential for patient safety and product consistency.

In contrast, other types of applications such as an Abbreviated New Drug Application (ANDA) are used primarily for generics; New Drug Applications (NDA) are for new products, and Investigational New Drug applications (IND) are for drugs that are still under investigation and not yet available on the market. These applications serve different purposes and correspond to different stages in the drug development and approval pipeline, which is why they are not appropriate in this context regarding post-marketing changes.