Which document indicates approval from the FDA for a new drug?

The correct answer is the New Drug Application, commonly referred to as NDA. This document is the formal application submitted to the FDA by a drug manufacturer seeking approval to market a new drug. The NDA includes a comprehensive collection of data about the drug, including results from preclinical studies and clinical trials, information about the drug's ingredients, and details on manufacturing processes. Once the FDA reviews this application and determines that the drug is safe and effective for its intended use, it grants approval, allowing the drug to be marketed.

In contrast, the Investigational New Drug Application (IND) is submitted before clinical trials begin. It allows a sponsor to start testing a new drug in humans; however, it does not indicate that the drug has been approved for marketing. A Supplemental New Drug Application (SNDA) is used when a manufacturer wishes to make changes to an already approved drug, such as changes in formulation or labeling, rather than to initiate marketing of a new drug. The Abbreviated New Drug Application (ANDA) is used for the approval of generic drugs and does not apply to new drug approvals but rather to drugs that are already on the market.