Issue Date: December 16, 2008
Issued by: Center for Drug Evaluation and Research
Topic(s): Chemistry, Manufacturing, and Controls (CMC), Pharmaceutical Quality
Status: Final
Orally Disintegrating Tablets: Guidance for Industry
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.
Download the Guidance Document
