In a single ANDA for an oral solid dosage form, which variation can be included assuming other parameters remain unchanged?

The correct choice highlights that different strengths can be included in a single Abbreviated New Drug Application (ANDA) for an oral solid dosage form, assuming that other parameters related to the formulation remain unchanged.

In regulatory terms, an ANDA allows a company to seek approval for a generic version of a drug that is already approved. The FDA permits variations in dosage strengths within the same ANDA to streamline the approval process, given that the formulation, manufacturing processes, and release specifications demonstrate bioequivalence to the reference listed drug. This flexibility supports the market needs for different dosages while maintaining a single application.

Conversely, the inclusion of different packaging methods or manufacturing sites would generally require separate submissions due to the potential impact on drug quality, safety, and efficacy. Each manufacturing site must demonstrate compliance with Good Manufacturing Practices (GMP), and variations in packaging can affect stability, storage, and administration of the drug. Additionally, different indications for use would necessitate a different evaluation, as this would imply that the drug is being used for a different therapeutic purpose, which is beyond the original scope of the ANDA.

Understanding these distinctions is crucial for both regulatory compliance and effective product management in the pharmaceutical industry.