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  • January 3, 2026

What Is an ANDA? The Complete Guide to Abbreviated New Drug Applications and FDA Approval

What Is an ANDA? The Complete Guide to Abbreviated New Drug Applications and FDA Approval

An ANDA is the FDA pathway that allows generic drugs to enter the market without repeating costly clinical trials. It saves billions annually and makes essential medicines affordable. Here's how it works, why it matters, and what you need to know.

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