Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules

3 October 2022 — FDA published final guidance on physical attributes of generic tablets and capsules for industry.

Tablets and capsules are widely manufactured and prescribed and may provide a number of advantages over other dosage forms, including ease of storage, portability, ease of administration, and accuracy in dosing. The recommendations in this guidance apply to abbreviated new drug applications (ANDAs) and their supplements for additional strengths that are submitted to the Office of Generic Drugs (OGD).

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