The size, shape, and score of a drug product are critical physical attributes that directly impact patient compliance, dosing accuracy, and overall product acceptability. When submitting to the FDA, ensuring that these characteristics align with the Reference Listed Drug (RLD) is essential for demonstrating equivalence in an Abbreviated New Drug Application (ANDA).

      A detailed comparison of size, shape, and score helps to confirm that the generic product will be perceived and used similarly to the RLD by healthcare providers and patients. This comparison is also vital in preventing medication errors and ensuring that the generic product meets all FDA requirements for substitutability. By adhering to this template, companies can better align their products with FDA expectations.