ANDA stands for which of the following?

ANDA stands for which of the following?

• A. Accredited Novel Drug Approval
• B. Abbreviated New Drug Application
• C. Additional New Drug Analysis
• D. Advanced New Drug Assessment

Answer: (B)

Abbreviated New Drug Application. This is the FDA submission used to seek approval for generic versions of drugs that already have an approved reference product. Because the reference product’s safety and efficacy are already established, the generic company can rely on those data and only needs to demonstrate bioequivalence, not repeat full clinical trials. The “abbreviated” part reflects these reduced data requirements compared with a new drug application. The other options aren’t recognized FDA pathways for approving generics.

Abbreviated New Drug Application. This is the FDA submission used to seek approval for generic versions of drugs that already have an approved reference product. Because the reference product’s safety and efficacy are already established, the generic company can rely on those data and only needs to demonstrate bioequivalence, not repeat full clinical trials. The “abbreviated” part reflects these reduced data requirements compared with a new drug application. The other options aren’t recognized FDA pathways for approving generics.