Tag: ANDA approval

How Long Does the FDA Take to Approve Generic Drugs? 2025 Timelines Explained

How Long Does the FDA Take to Approve Generic Drugs? 2025 Timelines Explained

The FDA's generic drug approval timeline averages 10 months, but simple generics can be approved in under 40 days. Complex drugs take longer. AI, priority reviews, and new programs are speeding things up - here's how.

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