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Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guidance provides pharmaceutical manufacturers of new and generic drug products with an Agency perspective on the definition of an orally disintegrating tablet (ODT)—which is a different dosage form than, for example, a chewable tablet or a tablet that should be swallowed whole with liquid—and also provides recommendations to applicants who would like to designate proposed products as ODTs.
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:
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-2007-D-0365.