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GUIDANCE DOCUMENT

Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules October 2022

Final Level 2 Revised Guidance
Docket Number:
FDA-2013-N-1434
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-N-1434.

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