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GUIDANCE DOCUMENT

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

Download the Final Guidance Document Read the Federal Register Notice
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.

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

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Dockets Management
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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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